Senior Manager - CMC Regulatory
770 Lindaro Street San Rafael, CA 94901 US
Job Description
As a Senior Manager in the Regulatory CMC department this individual will be responsible/accountable for:
RESPONSIBILITIES
Planning, preparation and submission of global regulatory CMC-related content pertaining to clinical trial applications, marketing Application(s) and periodic reports for US and Ex-US markets in accordance with the developed regulatory strategy. Ensure that the sections are complete, well-written, and meet all relevant requirements.
Collaborating and staying aligned with Reg CMC Product Lead to assess change records of proposed manufacturing changes and provide strategic regulatory guidance for optimal implementation of changes.
Developing and reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
Manage the timelines and deliverables to ensure submissions are aligned with program milestones.
Proactively identify issues and escalate.
Develop relationships with Regulatory Affairs, Manufacturing, Technical Development, Sites, and Quality to support submission preparation.
Provide regulatory advice to technical subject matter experts based on knowledge of current Quality (CMC) requirements.
Process documentation requests to support key application activities
Manage interactions with country regulatory authorities (FDA, EMA, HC, etc) for assigned projects relating to health authority queries.
Requirements:
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.
- COMMUNICATIONS OPERATIONS
- REGULATORY AFFAIRS
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