Sr Manager, Regulatory Affairs

Thermo FisherSaint Louis, MO, US

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Job Title

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 Drug Substance Division

Discover Impactful Work :

Join our dynamic team and play a vital role in delivering life-changing therapies! Your work will be instrumental in ensuring compliance and supporting our mission to make the world healthier, cleaner, and safer.

A Day in the Life :

Serve as the primary contact for Site Regulatory Affairs
Coordinate regulatory assessments and filing management
Provide strategic regulatory support to project teams

Keys to Success :

Outstanding leadership and collaboration skills

Proven ability to manage staff and regulatory processes

Dedication to achieving flawless compliance

Education :

Bachelor's degree in a scientific or related field is mandatory.

Experience :

10+ years in a Quality role in a cGMP environment

5+ years managing people

5+ years regulatory experience in the biopharmaceutical industry

Knowledge, Skills, Abilities :

Strong understanding of global regulatory requirements

Highly effective verbal and written communication skills

Collaborative team member with strong communication abilities

Physical Requirements / Work Environment :

Office and laboratory settings, requiring occasional travel and adherence to safety protocols.

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 may be 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.

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Manager Regulatory • Saint Louis, MO, US