Senior Director, CMC Regulatory Strategy

Marea Therapeutics, Inc.; South San Francisco (CA); On-site; USD 260,000 - 295,000; Full time

Job summary

Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC submissions and alignment with Tech Ops.

On-site presence is preferred for at least two days per week in a SF-based office. The candidate will lead CMC strategy, manage regulatory interactions, and build a high-performing team to

Qualifications

• 15+ years of pharmaceutical or biotech industry experience, including 10+ years in CMC Regulatory Affairs for biologics.
• Bachelor’s Degree in biochemistry, chemistry, biology, or related pharmaceutical fields; advanced degree preferred.
• Direct CMC Regulatory Affairs experience supporting monoclonal antibody (mAb) development.
• Experience leading CMC interactions with regulatory health authorities (FDA/EMA/other).
• Proven track record creating and submitting CTA/IND and BLA/MAA filings for biologics.
• Strong knowledge of GMP, regulatory guidelines (ICH, FDA, EMA) for biologics; device combo products experience a plus.

Responsibilities

• Provide regulatory CMC strategic leadership to support development of Marea’s programs.
• Lead communications with regulatory agencies related to CMC strategies and issues.
• Manage preparation and submission of CMC portions of regulatory applications in the US and globally.
• Build and grow the Regulatory CMC function and team; align CMC strategy with overall regulatory plan.
• Oversee device-related CMC aspects for combination products; ensure phase-appropriate comparability needs.
• Ensure compliance with applicable regulations and mitigate regulatory risks.

Job description

Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC submissions and alignment with Tech Ops.

On-site presence is preferred for at least two days per week in a SF-based office. The candidate will lead CMC strategy, manage regulatory interactions, and build a high-performing team to