Senior Staff Regulatory Specialist, Pharmaceuticals

Welcome to Stryker, a global leader in the medical technology industry, where innovation and excellence are the hallmarks of our company. We are seeking a highly experienced Senior Staff Regulatory Specialist to join our dynamic team in the pharmaceutical division. In this role, you will play a critical role in ensuring compliance with regulatory requirements for our pharmaceutical products. Your expertise and knowledge will be vital in guiding our company towards success and maintaining the highest standards of quality and safety. If you are a driven and detail-oriented individual with a deep understanding of pharmaceutical regulations, we invite you to apply for this exciting opportunity.

1. Develop and maintain a thorough understanding of global pharmaceutical regulations and guidelines, including FDA, EMA, and other international regulatory bodies.
2. Serve as the primary point of contact for all regulatory inquiries and issues related to pharmaceutical products within the company.
3. Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure that all pharmaceutical products and processes comply with regulatory requirements.
4. Conduct thorough reviews of product labeling, packaging, and promotional materials to ensure compliance with regulatory guidelines.
5. Prepare and submit regulatory submissions, including new drug applications, supplements, and annual reports, to regulatory authorities.
6. Monitor and analyze changes in regulatory requirements and communicate potential impacts to relevant stakeholders.
7. Lead and participate in regulatory agency inspections and audits, providing necessary documentation and responses.
8. Communicate with regulatory agencies on behalf of the company to resolve any issues or inquiries.
9. Develop and maintain regulatory strategies for new and existing pharmaceutical products, ensuring timely and successful market authorization.
10. Mentor and train junior regulatory team members on pharmaceutical regulations and guidelines.
11. Continuously assess and improve internal processes and procedures to maintain compliance with regulatory requirements.
12. Stay updated on industry trends and best practices in regulatory affairs, and provide recommendations for process improvements and efficiencies.
13. Act as a subject matter expert on pharmaceutical regulations and provide guidance and support to cross-functional teams on regulatory matters.
14. Represent the company in industry meetings and conferences related to pharmaceutical regulations.

According to JobzMall, the average salary range for a Senior Staff Regulatory Specialist, Pharmaceuticals in Raleigh, NC, USA is $78,000-$102,000 per year. This may vary depending on the specific company, experience level, and other factors.

Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.