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 GRL 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.
Required Skills
Bachelor’s degree with minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
Strong knowledge and understanding of global regulatory requirements, including interpretation of regulations, guidelines, and policy statements
Demonstrated ability to manage regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA).
Excellent operational competencies, including planning, organization, and project management skills.
Strong oral and written communication skills, with the ability to clearly convey regulatory concepts and updates to cross-functional teams.
Proven ability to build collaborative relationships across functions and contribute to innovative problem-solving.
Experience with regulatory systems and tools such as Veeva Vault, Docubridge, and CTIS.
Ability to work independently and serve as a reliable team member in a fast-paced, matrixed environment
Preferred Skills
Management of CTA
Supporting BLA
Additional Information
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:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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 our DE&I efforts.
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.
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