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| Job ID: |
SM-011910-1 - Associate Director, Clinical Regulatory Affairs |
| Description: |
Job Summary:
The Associate Director, Clinical Regulatory Affairs, provides leadership to oversee the development and implementation of sound regulatory strategies for multiple products, influences significant inter-organizational operations, and is responsible for development of direct reports and management of departmental resources.
Job Duties/Responsibilities:
-Provides leadership to oversee the development and implementation of sound national and international regulatory strategies for multiple products
-Has strategic responsibility for areas of limited to significant corporate impact
-Has a 6 month to 2 year planning horizon to ensure needs of the department and company are met
-Assures that original INDs, NDAs, BLAs, MAAs, and major supplements, amendments and variations thereto, are prepared to meet the highest regulatory standards for content and format, and are consistent with the company goals
-Creates and maintains good working relationships with FDA reviewers and directors
-Provides final review and sign-off for submissions as directed by VP
-Provides leadership for the development of policies and procedures relating to submission content and Regulatory Agency interface
-Works with peers to develop departmental guidelines
-Ensures that Regulatory Affairs is appropriately represented on project teams, and that regulatory support is provided to staff of other departments within company
-Provides leadership in interactions with collaborators
-Manages multiple Regulatory Affairs professionals. Recruits, selects, trains, appraises performance, administers salaries and provides development opportunities for reporting employees.
-Ensures adequate succession planning
-Serves as coach and mentor to departmental members
-Influences long-term regulatory strategies for company- and industry-wide via trade organizations and interactions with regulatory agencies
-Influences significant inter-organizational operation matters, e.g., projects and workflow
-Coordinates/prioritizes resources and people to meet the needs of the projects
-Works with departmental management on the development of budgets, LRPs, etc.
-Responsible for oversight of all regulatory activities on preparation of BLA/NDA/MAA filings
-Represents regulatory at intra-company decision making meetings on broad clinical strategies
-Sponsors and/or Chairs RAC (Regulatory Advisory Committee)
-Represents Regulatory at corporate committees (PPC, DRC, RAC, etc)
-Prepares teams for and presents at FDA Advisory Committees
Qualifications: Education, Experience, Knowledge and Skills: (Minimum requirements)
-BS degree in life sciences
-A minimum of 10 years experience in the pharmaceutical or biotech field with at least 5 years direct managerial responsibility, and minimum of 5 years Clinical Regulatory experience
-Experience managing group of >10 Regulatory staff members of various job levels
-Experience providing strategic oversight and management for a group of Immunology products in all stages of development including early development through filing and post-marketing activities
(Preferred requirements)
-Advanced degree
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Salary: 150-180k,
Job Type: Permanent,
Total Exp: 4-10,
Location: San Francisco |
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| Job ID: |
CM-11189-1 - Director of Regulatory Affairs and Quality Assurance |
| Description: |
The primary portfolio compound is a recombinant protein in Phase 3, our preferred candidate needs to have experience in the quality aspects of moving a biologic into commercialization using a large number of external contract organizations.
Provide regulatory input at all stages of product lifecycle for pre clinical support and strategic leadership.
Guide both internal and external resources in Regulatory and Quality programs.
Inspects and qualifies
Prepares Regulatory Reports
Frequent contact with consultants, reg agencies and corporate partners
Prepare company personnel for FDA interactions,
Content management for reg submissions
Evaluate submissions for accuracy quality and compliance
Prepare amendments
Experience:
Track record of positive outcomes in critical regulatory authority interactions.
Recombinant Protein experience, along with
Conduct in house regulatory authority meetings
Progressive responsibility in managing resources
IND, NDA, BLA experience
CDER track record
Knowledge of all relevant pharma regulatoy procedures and reporting requirements
Experience with document management of INDs IND amendments FDA Briefing Packages, and NDAs
10 years + in Phamaceutical/Biologics
Phase III experience preferred.
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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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SM-011910-2 - Manager, Clinical Regulatory Affairs |
| Description: |
Job Duties/Responsibilities:
Serves as the regulatory representative on multiple projects and represents a complete regulatory strategy, including CMC and commercial and leads the regulatory sub team
* Provides regulatory due diligence assessments in cooperation with business development
* Presents regulatory strategies and issues at corporate committees/senior management
* Serves as the primary liaison with regulatory authorities
* Manage within a 6-12 month planning horizon
* Demonstrate leadership in defining novel approaches to product development and approval
* Collaborate with senior management on relevant long term regulatory strategies to ensure effective achievement of regulatory/business objectives
* Exerts influence in the development of overall objectives and long-range goals
* Manage and develop one or more associates and/or managers
* Makes sound, independent decisions which may have long-term impact
* Participates in defining the business unit objectives, timelines, human resources matters and allocation of resources
* Frequent interactions with senior level management and external representatives concerning business unit operations
* Lead cross-functional teams in the coordination of regulatory submissions
* Work collaboratively with business partners
* Leads and participates in department initiatives, task forces, and training
* Provide leadership in researching, recommending and implementing new processes in the department/company
* Continue to expand your knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics
Competencies Identified for Success:
* Business knowledge
* Developing self and others
* Leading innovation and change
* Strategic agility
Qualifications: Education, Experience, Knowledge and Skills:
(Minimum requirements)
* Education: Bachelor's degree required
* Years of Experience: Ten or more years drug development or related experience
* Skills: strategic agility, ability to work well under pressure, influence at all levels without authority, strong interpersonal skills, relationship building, work in a team environment, flexibility and willingness to adapt in a changing environment. Demonstrate leadership, sound decision-making, negotiation and problem solving skills in an independent manner.
(Preferred requirements)
* Degree in science
* Seven or more years experience in Regulatory Affairs
* Three or more years in a supervisory role
* Advanced degree
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Salary: 120-140K,
Job Type: Permanent,
Total Exp: 4-10,
Location: San Francisco |
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TA-012810-1 - Sr. CMC Regulatory Support Associate |
| Description: |
GENERAL SUMMARY:
Individual will be a member of an interdisciplinary team that will provide support to the Regulatory Affairs (CMC) Organization. This team’s primary responsibility will be to provide the technical content for the Chemistry, Manufacturing and Controls (CMC) sections of all investigational drug applications (INDs, CTAs) and any required amendments, initial marketing applications along with any required supplements and amendments. Additional responsibilities include assisting the RA (CMC) Group with the compilation of the responses to the respective health authorities resulting from the noted filings, coordinating and synthesizing input from the required technical experts. Must be detail-oriented with good oral and written communication skills. Must be able to multi-task and to keep to the timelines established for the respective filings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Responsible for generating the technical content for the Chemistry, Manufacturing and Controls (CMC) documentation required for investigation new drug applications and their respective amendments as well as initial marketing applications along with the required supplements and amendments.
2. Using standardized templates prepare the respective technical sections for a given regulatory filing.
3. As required, coordinate the completion of the CMC templates with the Regulatory Affairs (CMC) Organization for those filings assigned.
4. Summarize technical reports and documents to meet the needs of a given template section.
5. Maintain a working knowledge of the project plans for those projects where you are a contributor to ensure that the CMC sections are delivered on time. As required, lead the efforts for a given filing. This will required a project plan to be maintained based on the deliverables established by the product project teams and the filing schedule established by the Regulatory (CMC) Affairs organization.
6. As required serve as a member of multi-disciplinary teams organized to ensure project timelines are met and clinical and commercial supplies are available when needed.
7. Assist manager with the preparation of an optimized work flow for document creation, review and completion.
ESSENTIAL KNOWLEDGE, SKILLS, & EXPERIENCE:
1. A minimum of 7 years Biopharmaceutical or Pharmaceutical Industry experience which should include 1-3 years of regulatory handling/authoring regulatory documentation or related experience. Credit given toward years of industry experience to those with advanced degrees.
2. A working knowledge of US regulatory requirements with global regulatory experience a plus.
3. A working technical knowledge of the biopharmaceutical manufacturing process preferably in the area of antibody manufacturing. Expertise in a technical discipline a plus.
4. BS//BA degree in Biochemistry, Chemistry, Microbiology, Pharmaceutics, Chemical Engineering or related field. An advanced degree a plus.
5. Working knowledge of cGMPs as they apply to the Regulatory environment.
6. Strong organizational skills.
7. Excellent communication skills, both oral and written with demonstrated skills in the preparation of complex regulatory filings.
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Salary: to 107K,
Job Type: Permanent,
Total Exp: 7 Yrs,
Start Date: ASAP,
Location: Bridgewater, NJ |
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TA-011610-1 - Sr. Manager, Regulatory Affairs Archives |
| Description: |
GENERAL SUMMARY:
The incumbent is responsible for ensuring that records within Regulatory Affairs are being managed in compliance with regulations and archiving best practices. The Senior Manager will also have responsibility for the management of department SOPs and Work Practices. The incumbent is responsible for providing supervision to direct reports. The Senior Manager will provide management and leadership for Regulatory Archives in the strategic planning, distribution and archiving of global Regulatory submissions and correspondence. This position requires attention to detail and the ability to be proactive to user needs. It is expected that the incumbent demonstrates understanding of and ability to provide customer service across various business lines within the balance of assuring the confidentiality of the regulatory archives.
The incumbent will also be the leading authority on the latest archiving technology and information tools in order to implement archiving systems that will aid in the streamlining of archiving documents, and facilitate easier search capabilities of the Regulatory Affairs electronic archives. This person must be highly organized, skilled in effective communication and negotiation, able to manage a growing group, with the ability to guide and coach employees. The incumbent must also be able to multitask, work well within the team setting, and prioritize work to meet critical timelines.
RESPONSIBILITIES:
1. Owns the maintenance of the Regulatory Archive (paper and electronic systems) by properly storing and retrieving documents in a timely manner according to processes and procedures.
2. Functions as a key liaison between Regulatory customers and the archive information. Partners or directs customers to specific authoritative sources of information to satisfy specific information needs.
3. Decision-maker for access to the collection of information of all media types and is a resource as a Subject Matter Expert for historical content of information processes.
4. Process owner for the roles and responsibilities of the eArchive database. Oversees that all requests for archiving are completed and closed according to written procedures. Reviews metrics reports and uses metric reports to identify trends and needs for training.
5. Responsible for coordination with Regulatory Liaison or Submissions Management to ensure that archive requests from other ImClone functions are properly coordinated before retrieval work is performed.
6. Manages collaboration with Regulatory Liaison to ensure that archive requests in support of audits are reviewed and provided to ImClone contacts prior to being sent to health authorities or internal/external inspectors and auditors.
7. Addresses any escalated problems and facilitates any business decisions pertaining to conflict management and process management.
8. Manages the SOP and Work Instruction process for the department.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1. Must have 4-7 years of pharmaceutical industry experience with a minimum of 3 years working with GxP documentation.
2. Bachelor Degree or equivalent experience. Working knowledge of global Regulatory submission experience is required.
3. Must have basic knowledge of the drug development process, Health Authority regulations and guidance documents (US, EU, CAN) and ICH technical aspects of product development and registration.
4. Knowledge and experience in developing and managing SOPs and work instructions.
5. Working knowledge of CTD/eCTD in both regulatory and technical perspectives.
6. Basic knowledge with process development and compliance to SOPs and Work Instructions. Working knowledge with industry best practices and standards.
7. Must have effective verbal and written skills.
8. Must be able to establish and maintain relationships with various internal and external colleagues.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 4-7 Yrs,
Start Date: ASAP,
Location: Bridgewater, NJ |
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TA-011210-1 - Sr. Manager, Regulatory CMC |
| Description: |
Job Summary:
The incumbent is responsible for maintaining competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards, with an ability to evaluate same for impact on tactical operations. Good technical knowledge, provides committed, value-added effort in support of development projects and approved products. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents and manage the quality review process. Excellent time management skills essential; must be able to multi-task and drive timelines for deliverables. The position is primarily tactical however strategic insight is required. The Senior Manager is expected to work with minimal supervision.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1. Will have an in-depth understanding of regulatory CMC requirements, including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive).
2. Reviews websites and develops initial impact assessment of draft regulatory guidance, communicating changes in regulatory requirements to senior regulatory management.
3. Provides regulatory guidance to ensure development activities are compliant with relevant regulations and in line with current global guidance.
4. Communicates regulatory strategy and guides manufacturing in developing data for approval of post-marketing changes.
5. Works with development teams and Regulatory Operations to outline submission requirements and negotiate timelines for regulatory CMC submissions.
6. Prepares the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions.
7. Reviews and assesses the regulatory impact of all change controls/requests for the manufacture, testing and release of development and marketed products.
8. Assists in the implementation of processes and applications to support regulatory activities
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:
1. Must have 4 – 7 years of pharmaceutical industry experience including a minimum of 3 years of regulatory or related experience.
2. Demonstrated knowledge of the drug development process and government regulations/guidelines, including US and international product registration.
3. Good oral and written communication skills with a focus on accuracy (vigilant attention to detail) and clarity are essential.
4. The Senior Manager will have the ability to supervise and mentor junior staff members.
5. BA/BS degree or equivalent experience.
Travel Requirements: Up to 10%
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: Bridgewater, NJ |
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