Regulatory Affairs Associate - III
GDH

Job Info

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Job Posting Title: Regulatory Affairs CMC Sr. Associate (consultant)
*The candidate has to be higher level (Sr Level with extensive CMC background)
*Location: Morris Plains, NJ.
**The role the manager is looking for is a Senior level Associate with :
MUST HAVE CMC and 5+ years of relevant experience in Regulatory Affairs CMC.::
Specific Responsibilities: The Regulatory Affairs CMC Sr. Associate will provide Regulatory CMC support for biologic and small molecule investigational drugs being evaluated for the treatment of oncology, HIV and liver diseases. The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities. May serve as Regional Lead on cross-functional/ cross-regional Regulatory Submission Teams. May participate on other Subteams, as applicable.

Essential Duties and Job Functions: Responsible for preparing and submitting regulatory documents which require interaction with departments outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals. Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks. Responsible for regulatory operational activities including organizing, tracking, and sending submissions for publishing for the US and other International Markets. Compiles documentation for regulatory submission packages including license renewals, updates, and market registration for review and submission to regulatory agencies.Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable. Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and regulatory project teams in a timely manner.

Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information. Provide support for cGMP activities as they relate to regulatory affairs CMC`.

Work is performed cross-functionally within a matrixed organization. under limited direction of a senior Regulatory Affairs CMC professional and line manager.

Knowledge, Experience and Skills: Requires a Bachelors degree (scientific filed preferred) and 5+ years of relevant experience in Regulatory Affairs CMC.
Experience with BLA submissions desired.
Excellent organizational skills and ability to work on a number of projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are expected.
Must work well under demanding deadlines and have excellent attention to detail.
Must be knowledgeable of regulatory requirements, including ICH requirements and US regional requirements
Onsite Offsite: Onsite
Have you already identified a candidate: No
Pre-Identified Candidate result: End Pre-Identified Candidate

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