Senior Manager, Regulatory Affairs

Are you a highly experienced regulatory affairs professional looking for a new challenge? Look no further than AbbVie! We are currently seeking a Senior Manager of Regulatory Affairs to join our dynamic team. In this role, you will be responsible for leading and overseeing regulatory activities for our innovative pharmaceutical products. As a key member of our organization, you will have the opportunity to collaborate with cross-functional teams and make a significant impact on the success of our products. If you have a passion for regulatory compliance and a desire to drive forward meaningful initiatives, we want to hear from you. Join us at AbbVie and help us make a difference in the lives of patients around the world.

1. Develop and implement regulatory strategies for AbbVie's innovative pharmaceutical products, ensuring compliance with all relevant laws and regulations.
2. Serve as the primary point of contact for regulatory agencies and lead communications and negotiations related to product submissions and approvals.
3. Oversee the preparation and submission of regulatory documents, including INDs, NDAs, and BLAs.
4. Stay up-to-date on changes in regulatory requirements and proactively identify potential risks and opportunities for AbbVie's products.
5. Collaborate with cross-functional teams, including R&D, clinical development, and commercial, to ensure regulatory compliance and alignment with business objectives.
6. Lead the planning and execution of regulatory activities and timelines, ensuring timely submission and approval of products.
7. Manage and mentor a team of regulatory professionals, providing guidance and support to ensure high-quality work.
8. Monitor and track all regulatory submissions and approvals, and provide regular updates to senior management.
9. Represent AbbVie in industry forums and conferences, building relationships with key stakeholders and staying abreast of industry trends and best practices.
10. Drive continuous improvement in regulatory processes and procedures to increase efficiency and effectiveness.
11. Collaborate with global regulatory teams to ensure consistency and alignment in regulatory strategies and submissions.
12. Adhere to all AbbVie policies and procedures, including compliance with all applicable laws and regulations.
13. Act as a subject matter expert on regulatory matters and provide guidance and support to other departments as needed.
14. Foster a culture of compliance and ethical behavior within the regulatory affairs team and across the organization.
15. Contribute to the development of AbbVie's regulatory strategy and support business development activities as needed.
16. Demonstrate a commitment to continuous learning and professional development to stay current with evolving regulations and industry standards.

According to JobzMall, the average salary range for a Senior Manager, Regulatory Affairs in North Chicago, IL, USA is $150,000-$175,000 per year. However, this can vary depending on factors such as education, experience, and the specific company and industry. Some Senior Managers in this role may make more than $200,000 per year, while others may make less than $150,000.

AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.