Biogen
About This Role
The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team.
What You'll Do
Collaborate with the Global Regulatory Lead to support regulatory strategy and execution for assigned programs.
Participate in cross-functional project teams to provide regulatory input and ensure alignment on submission planning and labeling strategy.
Lead or support the review of regulatory submission packages, including INDs, CTAs, NDAs/BLAs, and supplemental submissions.
Manage health authority query responses, ensuring timely and accurate communication and resolution.
Coordinate with Regulatory Operations and CROs to facilitate submission logistics and document delivery.
Provide guidance on US labeling precedence and support implementation of US labeling across functions.
Maintain and update regulatory systems (e.g., GRIT) to reflect submission approvals related to supply release.
Serve as a backup for other regulatory team members during absences, ensuring continuity of regulatory support.
Who You Are:
You are a hands-on Global Regulatory Affairs professional with experience managing and supporting IND, CTA, NDA, and BLA submissions across multiple regions and working directly with health authorities and cross-functional development teams. You thrive in a fast-paced biotech environment, bringing strong regulatory execution, project management, and submission expertise to drive programs forward while ensuring global regulatory compliance.
Required Skills
Preferred Skills
Job Level: Management
Additional Information
The base compensation range for this role is: $140,000.00-$187,250.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.