Senior Staff Regulatory Specialist, Pharmaceuticals

Welcome to Stryker, a leading global medical technology company dedicated to improving patient care. We are seeking a highly skilled and experienced Senior Staff Regulatory Specialist to join our dynamic team in the pharmaceutical division. As a Senior Staff Regulatory Specialist, you will play a critical role in ensuring our pharmaceutical products meet all regulatory requirements and maintain compliance with global regulations. We are looking for a detail-oriented individual with a strong understanding of the pharmaceutical industry and regulatory landscape. If you are passionate about making a difference in the lives of patients and possess the necessary qualifications, we invite you to apply for this exciting opportunity at Stryker.

1. Develop and maintain a thorough understanding of global pharmaceutical regulations and standards.
2. Ensure all pharmaceutical products meet regulatory requirements and maintain compliance with global regulations.
3. Review and approve product labeling, packaging, and advertising materials to ensure compliance with regulatory guidelines.
4. Lead the preparation and submission of regulatory documents and reports to regulatory agencies.
5. Collaborate with cross-functional teams, such as R&D and Quality Assurance, to ensure regulatory requirements are met throughout the product development process.
6. Conduct risk assessments and provide recommendations for mitigating regulatory risks.
7. Stay up-to-date on changes and updates to regulatory requirements and communicate any potential impact to the organization.
8. Develop and maintain relationships with regulatory agencies and serve as the primary point of contact for all regulatory inquiries.
9. Train and mentor junior regulatory staff on regulatory requirements and processes.
10. Participate in internal and external audits to ensure compliance with regulatory requirements.
11. Identify and implement process improvements to streamline regulatory processes and increase efficiency.
12. Represent the company in regulatory meetings, conferences, and other industry events.
13. Maintain accurate and up-to-date records and documentation related to regulatory activities.
14. Ensure timely and accurate completion of all regulatory submissions and responses to agency inquiries.
15. Collaborate with the legal team to monitor and address any potential legal or compliance issues related to pharmaceutical regulations.

According to JobzMall, the average salary range for a Senior Staff Regulatory Specialist, Pharmaceuticals in Chicago, IL, USA is $100,000 to $120,000 per year. However, this can vary depending on factors such as the specific company, years of experience, and additional qualifications or certifications.

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.