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Senior Manager - CMC Regulatory

San Rafael, CA 94901

Posted: 01/24/2025 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 617079 Is job remote?: No Country: United States

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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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!

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