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Lead Regulatory Affairs Strategist
2 months ago
Thermo Fisher Scientific is seeking a seasoned professional in Regulatory Affairs to become part of the Bio-Sciences Division team. This position offers the flexibility of remote work.
Key Responsibilities:
- Formulate and execute comprehensive global regulatory strategies.
- Oversee the development of FDA pre-submission packages and facilitate meetings.
- Draft and finalize product submissions.
- Provide expert guidance on regulatory submissions.
- Evaluate advertising and promotional materials for regulatory compliance.
- Serve as a subject matter expert in regulatory matters.
- Conduct training sessions for team members.
- Support New Product Introduction (NPI) initiatives.
- Engage with both internal and external stakeholders collaboratively.
- 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.
- Demonstrated experience in leading effective teams.
Essential Skills:
- Exceptional communication and leadership abilities.
- A mindset focused on continuous improvement.
- Capability to offer solutions grounded in expertise and experience.
- Willingness to travel as required.
Compensation and Benefits:
The salary range for this role in Texas is $118,000 to $177,000.This position may qualify for a variable annual bonus based on performance metrics. The organization provides a comprehensive Total Rewards package, which includes medical, dental, and vision insurance, paid time off, parental leave, a retirement savings plan, and a stock purchase plan.
