Job Description
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 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
