Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD® clinical research portfolio, our work in evidence-based solutions specializes in generating the evidence needed to optimize the commercial potential of our biopharma and biotech customers’ products. Your determination to demonstrate effectiveness, safety and the value of these products will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

St. Louis, Missouri

Onsite role – Drug Substance site Discover Impactful Work:

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.

A day in the Life:

• 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

Keys to Success:

• 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

Education

• Bachelor’s degree or equivalent in a scientific or related field.

Experience

• 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

Knowledge, Skills, Abilities

• 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

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

• Relocation assistance is provided.
• 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.