Senior Manager, Compliance Affairs
2 weeks ago
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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