
Senior Director, RA Global Therapeutic Area Head
Welcome to AbbVie, a global biopharmaceutical company dedicated to improving the lives of patients around the world. We are seeking a highly experienced and driven Senior Director, RA Global Therapeutic Area Head to lead our rheumatology franchise and shape our global regulatory strategy.As the Senior Director, RA Global Therapeutic Area Head, you will play a critical role in driving the development, registration, and commercialization of innovative treatments for rheumatoid arthritis. You will lead a team of regulatory experts and collaborate with cross-functional teams to ensure compliance and success in regulatory submissions.To excel in this role, you must have a deep understanding of global regulations and a proven track record of successfully leading regulatory strategies in the pharmaceutical industry. You should possess strong leadership skills and the ability to work effectively in a fast-paced, dynamic environment.If you are passionate about making a meaningful impact in the lives of patients and are ready to take on a leadership role in a global organization, we encourage you to apply for this exciting opportunity at AbbVie.
- Develop and execute global regulatory strategies for the rheumatology franchise, in alignment with the company's overall objectives and goals.
- Lead a team of regulatory experts and provide guidance and mentorship to ensure high-quality and timely regulatory submissions.
- Collaborate with cross-functional teams, including clinical development, medical affairs, and commercial teams, to ensure regulatory compliance and successful product development.
- Stay up-to-date with global regulations, guidelines, and industry trends related to rheumatology products, and incorporate them into the company's regulatory strategy.
- Plan and lead regulatory authority interactions and meetings, including pre-submission meetings, scientific advice meetings, and regulatory agency inspections.
- Oversee the preparation, review, and submission of all regulatory documents, including INDs, NDAs, BLAs, and other relevant submissions.
- Monitor and communicate changes in regulatory requirements and potential risks that may impact the company's product development and commercialization plans.
- Represent the company in external forums, such as industry conferences and regulatory meetings, to enhance the company's reputation and influence in the regulatory landscape.
- Develop and maintain strong relationships with regulatory agencies and key stakeholders to facilitate efficient and effective communication and collaboration.
- Ensure compliance with all applicable laws, regulations, and company policies related to regulatory affairs.
- Provide strategic input and recommendations to senior leadership on regulatory matters and contribute to the overall business strategy.
- Foster a culture of excellence, innovation, and continuous improvement within the regulatory team.
- Mentor and develop team members to enhance their skills and capabilities and foster their career growth.
- Prepare and manage the departmental budget and resources effectively to achieve business objectives.
- Act as a subject matter expert on global regulatory affairs and provide guidance and support to other departments as needed.
Advanced Degree In A Relevant Field (E.g. Pharmacy, Life Sciences, Regulatory Affairs)
Minimum Of 10 Years Of Experience In Regulatory Affairs, With At Least 5 Years In A Leadership Role
In-Depth Understanding Of Global Regulatory Requirements And Processes For Drug Development And Commercialization
Proven Track Record Of Successfully Leading And Managing Global Regulatory Submissions And Approvals
Strong Leadership And Communication Skills, With The Ability To Collaborate And Align With Cross-Functional Teams And External Stakeholders.
Strategy
Team Management
Budget management
Leadership
Compliance
Risk assessment
Product Lifecycle Management
Stakeholder engagement
Cross-Functional Collaboration
Regulatory Affairs
Global Markets
Pharmaceutical Industry
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Director, RA Global Therapeutic Area Head in North Chicago, IL, USA is $210,000-$250,000 per year. However, this can vary greatly depending on the specific company, industry, and individual qualifications and experience.
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AbbVie is an American publicly traded biopharmaceutical company founded in 2013. It originated as a spin-off of Abbott Laboratories.

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