Senior Manager - CMC Regulatory from Joulé

Job Title: Senior Manager - CMC Regulatory
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.

• 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.