Sr Manager Regulatory Affairs

Thermo Fisher Scientific•St. Louis, MO

2d•Onsite

About The Position

Join our dynamic team and play a vital role in delivering life-changing therapies! In this position, you will play a critical role in ensuring our St. Louis Biologics site remains a trusted CDMO partner by delivering regulatory excellence, proactive risk management, and seamless support for sponsor interactions with FDA and international regulatory agencies. Your work will be essential to maintaining compliance and advancing our Mission to enable our customers to make the world healthier, cleaner, and safer. This role offers the opportunity to shape regulatory strategy within a dynamic CDMO environment, engage with complex global initiatives, and drive high-visibility, cross-functional impact across the organization. We are seeking a strong regulatory leader with demonstrated experience supporting biologic programs, bringing deep expertise in navigating complex global regulatory requirements within a cGMP manufacturing environment.

Requirements

8+ years in a Quality role in a cGMP environment
5+ years managing people
5+ years regulatory experience in the biopharmaceutical or CDMO related industry
Strong understanding of global regulatory requirements for biologic products, including experience interpreting and applying guidance across major health authorities (e.g., FDA, EMA) within a cGMP manufacturing environment
Experience authoring, reviewing, or supporting CMC sections for IND/BLA, and/or MAA submissions
Highly effective verbal and written communication skills
Collaborative team member with strong communication abilities
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Outstanding leadership and collaboration skills
Proven ability to manage staff and regulatory processes in a CDMO or biopharma environment
Ability to influence cross-functional stakeholders on regulatory risk

Responsibilities

Serve as the primary contact for Site Regulatory Affairs
Coordinate regulatory assessments and filing management
Collaborate cross-functionally to assess regulatory risk with process changes, tech transfers, comparability strategies, and lifecycle management activities across multiple client programs