Senior Manager, Compliance Affairs

2 weeks ago


Carlsbad, United States Thermo Fisher Scientific Full time

Thermo Fisher Scientific is seeking a seasoned professional in Regulatory Affairs to become a vital member of the Bio-Sciences Division team. This role offers the flexibility of remote work.

Key Responsibilities:

  • Formulate and execute comprehensive global regulatory strategies.
  • Oversee the preparation of FDA pre-submission documentation and coordinate meetings.
  • Draft and finalize product submissions for regulatory approval.
  • Provide expert guidance on regulatory submission processes.
  • Evaluate advertising and promotional materials for regulatory compliance.
  • Serve as a subject matter expert in regulatory matters.
  • Facilitate training sessions for team members.
  • Support New Product Introduction (NPI) initiatives.
  • Engage with both internal and external stakeholders for collaboration.
  • Lead discussions in FDA meetings.
  • Assist in the registration of products.

Qualifications:

  • A Bachelor's degree in a relevant discipline.
  • 7-10 years of experience in Regulatory Affairs.
  • Proficient understanding of regulatory strategy, design control, cGMP, and import/export regulations.
  • Proven experience in leading high-impact teams.

Essential Skills:

  • Exceptional communication and leadership abilities.
  • A mindset focused on continuous improvement.
  • Capability to offer solutions based on expertise and experience.
  • Willingness to travel as required.

Compensation and Benefits:

The salary range for this position in Texas is $118,000 to $177,000.

This role may qualify for a performance-based variable annual bonus. The company provides a comprehensive Total Rewards package, which includes medical, dental, and vision plans, paid time off, parental leave, a retirement savings plan, and a stock purchase plan.



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