Senior Manager - CMC Regulatory

1 Year (Extendable)

San Rafael, CA

Max PR: $70-80/hr

This role is Hybrid but candidates must be PST - West Coast California

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.

QUALIFICATIONS

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

Required

• COMMUNICATIONS OPERATIONS
• REGULATORY AFFAIRS