Associate Director, Regulatory Affairs - Global Labeling

Are you an experienced regulatory affairs professional with a strong background in global labeling? Are you looking for a new challenge in a dynamic and innovative biopharmaceutical company? If so, Gilead Sciences is seeking an Associate Director to join our Regulatory Affairs team and lead the development and management of global labeling strategies for our products. In this role, you will have the opportunity to collaborate with cross-functional teams and global regulatory authorities to ensure product labeling compliance and drive the success of our products in the market. We are seeking a highly motivated and detail-oriented individual with a minimum of 8 years of experience in regulatory affairs, specifically in global labeling. If you have a passion for making a difference in the lives of patients and are ready to take the next step in your career, we encourage you to apply for this exciting opportunity at Gilead Sciences.

1. Develop and implement global labeling strategies for Gilead Sciences products.
2. Ensure compliance with regulatory requirements and guidelines for product labeling.
3. Collaborate with cross-functional teams to gather and review data for labeling updates.
4. Manage all aspects of the labeling process, including submission, review, and approval.
5. Stay up-to-date on global regulatory changes and communicate their impact on product labeling.
6. Liaise with global regulatory authorities to resolve any labeling-related issues.
7. Provide guidance and training to other members of the regulatory affairs team on labeling requirements.
8. Develop and maintain strong relationships with internal stakeholders, including clinical, medical, and commercial teams.
9. Lead labeling negotiations with regulatory authorities to ensure timely product approvals.
10. Monitor and track global labeling regulations and incorporate them into labeling strategies.
11. Manage labeling-related timelines and ensure timely completion of labeling activities.
12. Oversee the preparation and submission of labeling-related documents to regulatory authorities.
13. Conduct risk assessments and develop risk mitigation strategies for labeling-related issues.
14. Ensure accuracy and consistency of labeling across all regions and countries.
15. Act as a subject matter expert on global labeling regulations and guidelines.
16. Drive continuous improvement initiatives to enhance the efficiency and effectiveness of labeling processes.
17. Participate in regulatory agency inspections and audits related to labeling.
18. Mentor and guide junior regulatory affairs team members on labeling processes and procedures.
19. Collaborate with other departments, such as marketing and legal, to ensure labeling is in line with product messaging and legal requirements.
20. Represent Gilead Sciences in industry conferences and meetings related to labeling.

According to JobzMall, the average salary range for a Associate Director, Regulatory Affairs - Global Labeling is $120,000 to $160,000 per year. However, salaries can vary significantly depending on the specific company, location, and level of experience. Some factors that may affect salary include the size and reputation of the company, the complexity of the products and regulations, and the individual's education and certifications. Additionally, individuals with a higher level of experience and specialized skills may command a higher salary.

Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.