Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

1 week ago

Cambridge, Massachusetts, United States Biogen Full time


About the Job Title & Company:
Welcome and get to know more about the exciting opportunity to join our team at Biogen as the Senior Director, Global Regulatory Strategy, Therapeutic Area Lead in Global Regulatory Affairs. Be responsible for developing regulatory strategies for programs supporting the neuromuscular and rare disease field.


About the Role:
The Senior Director is accountable for developing end-to-end US, Above-Country EU, and Global regulatory strategies, collaborating closely with regulatory product teams and cross-functional development teams. Effective communication and constructive relationships within the Biogen matrix are key. Engage with Biogen business partners, regulatory authorities, and oversee resources.


What You'll be Doing:
- Provide strategic regulatory leadership for various programs and regulatory agencies
- Ensure seamless Global Regulatory strategy collaboration
- Promote innovative regulatory solutions and advise on new regulatory requirements
- Communicate global regulatory strategy to senior leaders
- Demonstrate expertise in clinical development regulatory aspects


Who You Are:
If you are a Global Regulatory professional with a strong passion for science and a deep scientific background, this role is for you. As a leader, you possess a strategic and innovative style, combining flexibility with a sense of urgency in your work.


Required Skills:
- 15+ years of experience in drug development and regulatory affairs in biotechnology or pharmaceuticals
- Leadership experience in a regulatory affairs management role
- In-depth global regulatory experience in multiple regions
- Experience in managing others and developing practice rules and guidelines
- Proficiency in preparation of major regulatory submissions and interfacing with regulatory authorities


Education:
An advanced degree (Masters, PharmD, PhD) in a scientific discipline is required


Why Biogen?
Biogen's mission focusing on therapies for neurological and rare diseases unites us as a team. We are committed to making a positive impact on our patients' lives and medicine's future. Our culture values inclusion, diversity, and innovation, creating a strong, empowered team. Join us in pioneering and thriving together.


We are looking forward to working with you and having you as part of our innovative and inclusive team at Biogen.

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