| Job List |
| Job ID: |
TRS-02158-7 - Associate Director, Postmarketing Regulatory Affairs |
| Description: |
Description:
The incumbent will be responsible for, but not limited to the following:
Providing regulatory input into strategic marketing initiatives and ESI policies regarding advertising and promotional activities
Reviewing and approval of all advertising and promotional materials for assigned products to insure that they comply with FDA regulations
Developmenting, implementating and the maintaining of regulatory procedures regarding review of advertising and promotional materials for marketed products
Acting as regulatory liaison with co-promote partners regarding promotional review
Acting as DDMAC liaison for assigned marketed products to facilitate FDA review
Overseeing overall regulatory labeling function for marketed products
o Supervising of Regulatory Coordinator for Labeling
o Coordinating with package engineering group for labeling review and approval
o Creating and maintaining all labeling files, including labeling history, current labeling, and change control.
o Assuring utilization of most current labeling in marketing materials
Qualifications:
Minimum BS degree or higher in life science
Five years pharmaceutical regulatory experience
At least 2 years experience reviewing advertising and promotional materials for prescription drugs or biologics
2 to 5 years of US prescription drug labeling experience, including FDA labeling negotiations and Core Data Sheets (as they translate to local labeling)
Knowledge of FDA regulations and guidance documents regarding advertising/ promotion and labeling requirements
Good knowledge of MS Office applications (MS Word, Excel, PowerPoint)
Must be very detail oriented
Must be able to work in a team environment
Must be able to function under tight timelines |
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Salary: Open,
Job Type: Permanent,
Total Exp: 2-5 Yrs,
Start Date: ASAP,
Location: Woodcliff Lake, NJ |
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| Job ID: |
TRS-02158-9 - Associate Director, Regulatory Affairs - Sepsis/GI |
| Description: |
Description:
Develop, implement & execute regulatory strategic plans & best practice departmental procedures for the GI and Sepsis group
Provide regulatory guidance for top-level project development/core teams
Responsible for managing complex regulatory submissions & communicating regulatory issues to functional areas & transmitting regulatory concerns from functional areas to Sr. Management
Actively liaise with FDA & regulatory authorities to provide/solicit guidance & support for complex submissions
Research & develop regulatory intelligence concerning competitor products
Staff training/management & self-development: supervise Regulatory Managers & Associates providing guidance, training & development to staff members/teams
Qualifications:
BS in scientific discipline required (Life Sciences, Chemistry, Toxicology or Pharmacology) required, Advanced degree preferred
5-8 years pharmaceutical experience, at least 4 of which in the regulatory environment
Experience managing mulitple complex submissions & leading FDA or regulatory agency meetings preferred
Comprehensive knowledge of FDA rules, regulations & guidelines & their application in clinical research & development is essential
Experience in managing relationships and interfacing with regulatory bodies as an articulate communicator with strong negotiation skills a plus
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Salary: Open,
Job Type: Permanent,
Total Exp: 5-8 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-8 - Associate Director, Regulatory Affairs, CNS |
| Description: |
Description:
The incumbent is responsible for but not limited to the following:
Develop, implement and execute regulatory strategic plans and best practice departmental procedures for the therapeutic area group.
Provide regulatory guidance for top-level project development/core teams.
Actively liaise with FDA and regulatory authorities to provide/solicit guidance and support for complex submissions.
Research and develop regulatory intelligence concerning competitor products and disseminate competitive intelligence to project and core teams.
Staff training/management and self-development.
Qualifications:
Bachelors degree in scientific discipline required (Life Sciences, Chemistry, Toxicology or Pharmacology). Doctorate degree highly desired (e.g., MD, JD, Pharm D, or PhD in life sciences).
3-8 years FDA experience as Project Manager or Clinical Reviewer.
Expert understanding of pharmaceutical operations and regulatory compliance requirements together with broad understanding and experience of the clinical development process a plus.
Expertise in managing relationships and interfacing with regulatory bodies as an articulate communicator with strong negotiation skills a plus. |
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-8 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-6 - Associate Director, Regulatory Affairs, Nonclinical |
| Description: |
Description:
The incumbent is responsible for but not limited to the following:
- Regulatory expertise within at least 1 related area including clinical trial management, manufacturing, non-clinical testing and marketed products together with broad understanding & experience in the clinical development process
- Support regulatory strategy & contribute to its outcome within the Nonclinical area
- Advise management & recommend departmental operating procedures/policies to accomplish work more efficiently & with better quality control
- Define regulatory vision & strategy for achieving that vision and engages and motivates team to buy into vision and execute strategy.
- Contribute to development results by providing regulatory leadership & assume a supervisory and/or "subject matter expert" role with regard to regulatory issues.
Qualifications:
Associate Director: MD, JD, PharmD or Ph.D. in the life sciences highly desired. BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology)
Associate Director: Minimum 10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., manufacturing, clinical marketed products, etc.) preferably including some broader industry experience.
Must have experience in interacting with the appropriate regulatory bodies
Most posess in-depth knowledge of appropriate Code of Federal Regulations & Regulatory Guidance Documents
History of working in complex team environments with numerous/diverse stakeholders
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Salary: Open,
Job Type: Permanent,
Total Exp: 10-12 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
CLM-09277-2 - Director, Quality Assurance & Regulatory Compliance |
| Description: |
my client is a highly respected leader in the Pharmaceutical, Biotechnology and Medical Device Industries, provides clinical research consulting and management services. We are a rapidly growing CRO, offering competitive compensation and excellent benefits, in a fast-paced team oriented environment.
Purpose of Position:
The primary focus of this position is the overall management of the Quality Assurance/Regulatory Compliance and Central Files/Records Retention departments. Provides leadership and expertise to company's personnel to ensure compliance with global regulations regarding study conduct and management. Acts as primary liaison with other department heads for all quality assurance, regulatory compliance and records retention functions.
Requirements and Responsibilities:
Responsible for strategic planning and profitability of Quality Assurance and Regulatory Compliance services including resource management of QA personnel for client projects.
Responsible for oversight of all QA/Regulatory Compliance services and personnel. Client services include investigator site audits, clinical laboratory audits, vendor/contract research organization audits, clinical study report audits, regulatory document review for test article shipment authorization, informed consent review, case report form review, database audits and other clinical data management support activities.
Responsible for oversight of all company internal QA and Compliance activities including; internal systems audits, company SOP maintenance, Records retention and archiving, Training records maintenance and GCP training program.
Responsible for coordination and hosting of client audits and regulatory authority inspections, providing corporate responses to audit observations and facilitating remediation activities.
Responsible for the management and update of Corporate and QA/Compliance departmental SOPs.
Provides QA/Compliance input on client proposals and business development activities including occasional participation in client business presentations.
Provides and facilitates QA/Compliance reference support for all personnel.
Ensures adequate communication with sponsors, sites, and company's colleagues to ensure that projects meet standards of quality, effectiveness and compliance.
This job is performed in a normal office environment. Physical requirements include ability to operate a personal computer, and to work at a desk for long periods of time with occasional opportunity to move to other locations within the building and surrounding locations for meetings, to obtain information, etc.
Education & Experience:
Bachelors degree in business, biological sciences or related field is required. Advanced degree in health sciences or business is preferred.
A minimum of 8 years of Quality Assurance/Compliance or relevant experience in the pharmaceutical/device industry is required
In-depth knowledge of FDA GCP and ICH regulations/guidelines and their practical implementation with respect to quality assurance of clinical study conduct.
Must possess a strong knowledge of the medical and pharmaceutical industry
Excellent verbal and written communications skills, problem-solving ability, and interpersonal skills
Must be highly organized and able to manage others in order to accomplish objectives within tight deadlines
The preceding job description has been designed to indicate the general nature and level of work performed by employees with this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Atlanta, San Jose, San Diego |
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| Job ID: |
TRS-02158-10 - Manager, Regulatory Affairs - Oncology |
| Description: |
Description:
The incumbent is responsible for, but not limited to the following:
Support regulatory strategic plans and follows best departmental procedures for the commercial oncology products and related activities.
Prepare and submit applicable documentation to domestic health authorities in support of investigational and marketed products submissions.
Ensure all supporting documentation for submissions is accurate and in accordance with regulatory requirements.
Interact with internal teams and external stake holders regarding regulatory issues.
Provide regulatory guidance to project teams and individuals as required.
Research and develop regulatory intelligence and disseminate information to teams.
Self-development.
Qualifications:
Bachelors degree in scientific discipline required; advanced degree strongly preferred.
Minimum 3-4 years of regulatory experience.
Broad understanding of pharmaceutical operations and regulatory compliance requirements in conjunction with investigational and commercials product experience.
Experience with common technical document and electronic submissions is a plus.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-4 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
CLM-09277-4 - Manager/Senior Manager, Quality Assurance & Regulatory Compl |
| Description: |
Purpose of Position:
Management of Quality Assurance and Regulatory Compliance activities to support internal and external customers.
Requirements and Responsibilities:
Conduct Investigator site audits for client clinical studies
Conduct facility audits to qualify use in clinical studies (e.g. CROs, Clinical Labs)
Prepare clinical sites for FDA inspections
Perform Clinical Study Report audits
Perform Protocol, Informed Consent, CRF review
Review Regulatory documentation for Drug Shipment Authorization
Manage final and interim Database Audits, Query QA and Data Management QA support
Perform Internal Systems audits to ensure quality service to clients
Facilitate Client audits and FDA inspections at company's headquarters
Assist with writing and/or updating Corporate and Departmental SOPs.
Assist with development and maintenance of training programs relevant to GxPs
Communicate with sponsors, sites and Clinimetrics personnel to ensure standards of quality and compliance
Assist with QA/Compliance input on client proposals for Business Development.
Education & Experience:
Bachelor of Science (Masters degree desirable), RN or equivalent.
Minimum of 5 years of quality assurance, clinical research and/or related experience
Minimum of 2 years of compliance auditing experience or equivalent
Strong interpersonal, written and verbal communication skills
Strong problem solving and organizational skills.
Must be detail oriented and have excellent quality of work.
Strong knowledge of the pharmaceutical and/or medical device industry, Good Clinical Practices, US and International regulations
Must have excellent spreadsheet and word processing skills and a working knowledge of databases
Ability to exercise sound judgment in prioritizing, problem solving and decision making
Ability to clearly organize, plan and schedule tasks and communicate status of projects
Travel:
Ability to travel up to 30-50% if necessary.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: San Jose, CA |
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| Job ID: |
PCR-11047-1 - Pharmacovigilance & Risk Management Director |
| Description: |
Primary Role
Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
Under the oversight of the Sr Global Pharmacovigilance & Risk Management Director and in collaboration with key colleagues in PV&RM, the PV&RM Director is responsible for ensuring appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for assigned products, globally.
Responsibilities
Oversee investigational and postmarketing regulatory reporting and pharmacovigilance activities for assigned products
Lead the development and execution of risk management strategies and author internal risk management plans and risk management/pharmacovigilance plans for submission to global health authorities, as required
Medically review individual case safety reports from post-marketing surveillance, from interventional and observational clinical trials, and from compassionate/named patient use.
Oversee, prepare and review scheduled Periodic/Annual Reports (FDA) and Periodic Safety Update Reports (FDA and Global Regulatory Agencies)
Oversee, prepare and review responses to ad hoc regulatory queries
Assist the Sr Global Pharmacovigilance & Risk Management Director in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within R&D, and as part of the Global PV & RM organization
Lead pharmacovigilance activities as a member of drug development project teams; co-lead Safety Review Teams
Lead safety-labeling activities for assigned products.
Support the Qualified Person for Pharmacovigilance in the EEA relative to issues related to assigned products
Education & Experience Requirements
Include educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred.
Medical Degree required
Post-graduate training in a subspecialty preferred, with training in family practice or internal medicine desirable.
Will generally have at least 5 years of pharmaceutical industry experience, with the most recent 3 devoted to working within a global pharmacovigilance department
Key Skills and Competencies
Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Strong post-marketing and investigational event and aggregate assessment/review/ documentation skills; must have experience is writing/oversight of Annual Reports, PSURs, Type II Variations.
Must have a strong working knowledge of ICH guidelines, FDA & EMEA Regulations and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety.
Experience in communicating with the EMEA and/or FDA or other recognised local Competent Authorities.
Global drug safety experience preferred.
Ability to read, analyse and interpret scientific and technical journals.
Must have very strong English language writing skills and mature verbal communication and presentation skills.
Working knowledge of MedDRA coding and case series retrieval strategies.
Experience using a large-scale electronic data storage and retrieval system.
Requires strong attention to detail in composing and/or proofing materials, establishing priorities, scheduling and meeting deadlines.
Ability to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
Ability to work independently, take initiative and complete tasks to deadlines.
Proven ability to independently resolve problems and conflicts.
Excellent interpersonal, analytical, managerial, and organizational skills.
Demonstrated ability to motivate, mentor, influence and collaborate with others in a complex global organizational matrix.
Ability to empathise with and support staff working in other national environments.
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Salary: 220-250k,
Job Type: Permanent,
Total Exp: 7 Yrs,
Start Date: ASAP,
Location: Chesterbrook, PA |
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| Job ID: |
HR-09217-1 - RA/QA Advanced Engineer |
| Description: |
JOB SUMMARY: This role has RA/QA responsibility throughout the enterprise (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer).
ESSENTIAL DUTIES AND RESPONSIBILITIES Other duties may be assigned:
Serves as a primary point of contact for all quality & regulatory related matters.
Serves as product development core-team member.
Facilitates worldwide product registration and ensures post-market compliance.
Has primary responsibility for product verification and validation compliance.
Identifies, qualifies, audits and monitors supplier and internal quality performance.
Ensures appropriate controls (key metrics) are defined, implemented and satisfactorily completed for all product development, manufacturing and distribution operations.
Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and systemic customer satisfaction.
Ensures GCP compliance, supplies good clinical research and marketing support, and reviews/approves labeling, including advertisement and promotional literature.
Provides training to ensure proper implementation and use of quality tools and procedures as required.
Enables rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.
SUPERVISORY RESPONSIBILITIES:
May be responsible for directing the work efforts of QA/RA engineers and/or technicians.
QUALIFICATIONS:
Working knowledge of regulatory affairs (Pre-Market, Post Market, GXP)
Proven ability to resolve Marketing, Sales/Service, Supplier, Manufacturing, R&D & Customer issues
Quality/Regulatory Experience
Software development experience a plus, awareness a must.
Proficient with QSR, Medical Device Directive, GCP and ISO Quality System Standards
Excellent analytical decision making and problem solving skills
Track record of business and customer orientation
EDUCATION AND/OR EXPERIENCE:
B.S. in Engineering or Science accompanied with 2-6 years of QA/RA experience and/or B.S. in non-technical field accompanied with 6 years of QA/RA experience
CQA, CQE or RAC desired
Experience in a medical device or other FDA regulated industry required
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Salary: Open,
Job Type: Permanent,
Total Exp: 2-6 Yrs,
Start Date: ASAP,
Location: RTP, NC |
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| Job ID: |
RG-11267-1 - Regulatory Associate IV |
| Description: |
Job Description:
This position in Regulatory Affairs:
-involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of the company's preclinical and clinical drug development programs.
-provides guidance to multidiscplinary teams on the content, format, style of Regulatory submissions to Regulatory authorities.
-edits scientific sections of submission to comply with regulatory requirements.
-assists with the writing, review and preparation of IND applications amendments, annual reports and other regulatory documents and correspondence.
Strong organizational and negotiation skills, excellent written and verbal communication skills and an advanced proficiency in Microsoft Office and desktop publishing applications are necessary.
A minimum of a bachelor's degree in a scientific discipline, biomedical, engineering, or related area is required. Previous experience in pharmaceutical development with biotechnology products is highly desirable. RAC certification by the Regulatory Affairs Professional Society is desirable. The successful candidate must have three to five years of experience conducting regulatory activities. Previous global Regulatory experience, NDA or BLA experience, and electronic submission expertise are preferred. |
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Salary: to 95k,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
DS-01108-1 - Regulatory Manager |
| Description: |
This is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.
Currently looking for a Manager, Clinical Regulatory
GENERAL SUMMARY
Directly responsible for the organization and preparation of IND submissions. Coordinates the activities required to maintain the IND filings in Regulatory Compliance. Provides regulatory interpretation and guidance to functional groups. Participates in compliance activities including SOP creation / revision, and departmental training exercises.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.
1. Organize and manage the preparation (content and format) of submissions (INDs, IND amendments, BLAs and BLA supplements and periodic reports) to the FDA.
2. Coordinates activities required for timely and accurate reporting of information to the existing INDs.
3. Responsible for liaison activities with functional groups within ImClone related to assigned products / project areas.
4. Provides written interpretation of FDA regulations, guidance and guidelines obtained from review of the Federal Register, FDA Talk Papers and trade press to all applicable groups. Provide notification of key meetings.
5. Oversees the maintenance of company information in the FDA database of Clinical Trials.
6. Participates in the creation, review and revision of the department policies and standard operating procedures (SOPs).
7. Assist in developing and presenting department training sessions.
Minimum Experience:
1. BS degree in life science with 5-7 years of experience in the pharmaceutical industry with at least 3-5 years experience in regulatory affairs.
2. Must possess a through understanding of the drug development / regulatory process.
3. Experience in GCPs and regulatory compliance preferable.
4. Demonstrate a though knowledge of the intent, meaning, interpretation and application of FDA and ICH regulations. Knowledge of foreign regulations, guidelines and practices for conducting clinical investigations beneficial.
5. Skills essential to the position:
a. Attention to detail and accuracy
b. Flexible; ability to adapt to changing priorities
c. Ability to effectively communicate, coordinate and interact with all levels of management within other departments.
d. Self-starter
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Branchburg, NJ |
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| Job ID: |
CM-02157-1 - Sr. Director Clinical and Regulatory Affairs |
| Description: |
SUPERVISORY RESPONSIBILITIES
This position will lead a small staff who may be based in Princeton and/or the European Office
CORE COMPETENCIES
Excellent written and oral communication skills. Demonstrated scientific and regulatory skills and experience.
EDUCATION and/or EXPERIENCE REQUIRED
Minimum of a Bachelors degree in a scientific or health related discipline. A higher degree is strongly preferred.
Minimum of five years regulatory affairs experience directly related to human drug development. Experience with global product development and regulatory requirements preferred.
CERTIFICATES, LICENSES, REGISTRATIONS
Regulatory Affairs Certification is preferred
Duties and Responsibilities
Assure that currently marketed and potential new products meet the regulatory requirements of the United States, Europe, Japan and rest of the world health authorities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Act as a liaison between the company and the various government health authorities as needed.
Act as the interface between Regional/Local Regulatory groups and the clinical and pre-clinical functions.
Prepare submissions and negotiate requirements with company pre-clinical scientists, company medical personnel and regulatory agency personnel.
Interpret regulations and policies, review and critically assess scientific information.
Provide timely and accurate strategic regulatory guidance to a variety of individuals and departments within the company.
Provide input and guidance on global development plans and clinical development plans.
Prepare INDs, IMPDs, NDAs, CTDs, MAAs, etc.
SECONDARY RESPONSIBILITIES
Prepare and oversee preparation of routine submissions; e.g., IND annual reports. Review and approve clinical protocols, study reports, and investigator brochures. Evaluate preclinical and clinical data for regulatory adequacy. Review and approve clinical drug shipments. |
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Salary: to 160k + 20%,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Princeton, NJ |
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