St. Louis, Missouri, USA
7 days ago
Sr Manager, Regulatory Affairs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 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 AffairsCoordinate regulatory assessments and filing managementProvide strategic regulatory support to project teamsKeys to Success:Outstanding leadership and collaboration skillsProven ability to manage staff and regulatory processesDedication to achieving flawless complianceEducationBachelor’s degree in a scientific or related field is mandatory.Experience10+ years in a Quality role in a cGMP environment5+ years managing people5+ years regulatory experience in the biopharmaceutical industryKnowledge, Skills, AbilitiesStrong understanding of global regulatory requirementsHighly effective verbal and written communication skillsCollaborative team member with strong communication abilitiesPhysical 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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