Senior Regulatory Affairs Specialist

5 days ago


GondrecourtleChâteau, Grand Est, United States Abbott Full time
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in St. Paul, MN. As a key member of our regulatory department, you will play a critical role in ensuring efficient and compliant business processes.

Job Summary

The successful candidate will provide regulatory input to product lifecycle planning, assist in SOP development and review, and help maintain annual licenses, registrations, listings, and patent information. Additionally, they will negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Responsibilities
  • Assist in developing regional regulatory strategy and update strategy based on regulatory changes
  • Monitor impact of changing regulations on submission strategies and monitor applications under regulatory review
  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Maintain annual licenses, registrations, listings, and patent information
Requirements

To be successful in this role, you will need:

  • Bachelor's Degree or an equivalent combination of education and experience
  • 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals)
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area
  • Effective communication, preparation, and negotiation skills both internally and externally with various regulatory agencies
  • Able to work in a highly matrixed and geographically diverse environment
Benefits

As a valued member of our team, you can expect:

  • Competitive salary range: $72,700.00 – $145,300.00
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, student debt program, and education benefit
  • A company recognized as a great place to work in dozens of countries around the world
About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.



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