Senior Manager - CMC Regulatory

Company: Joul--
Location: San Rafael
Posted on: January 16, 2025

Job Description:

Job Title: Senior Manager - CMC Regulatory

Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
Location: Hybrid - Local to San Rafael, CA
Type: Contract


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.


Education: BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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