Sr Manager, Regulatory Affairs

Thermo Fisher Scientific • St. Louis, MO

97d

About The Position

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.

Requirements

• Bachelor’s degree in a scientific or related field is mandatory
• 10+ years in a Quality role in a cGMP environment
• 5+ years managing people
• 5+ years regulatory experience in the biopharmaceutical industry
• Strong understanding of global regulatory requirements
• Highly effective verbal and written communication skills
• Collaborative team member with strong communication abilities

Responsibilities

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

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Relocation assistance may be provided

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees