Sr. Manager, Global Regulatory Affairs

Biogen•Cambridge, MA

3d•$140,000 - $187,000•Hybrid

About The Position

As the US Regulatory Lead, you will be responsible for developing and executing US regulatory strategies as part of the Global Regulatory Affairs team. You will also oversee the preparation, submission, and management of regulatory filings interactions with the FDA. This role requires outstanding collaboration abilities, as you will play a key role in proactively identifying regulatory risks and developing mitigation strategies ensuring compliance with relevant regulatory requirements, company policies, and industry standards, ensuring impactful outcomes and solutions for patients. This is a hybrid role, requiring 3 days office attendance per week.

Requirements

Bachelor's Degree in Life Science or related discipline with 7 years experience, Masters degree with 5 years experience.
Strong and proven experience within the pharmaceutical/biotechnology industry, including significant experience in Regulatory Affairs Strategy
Hands-on experience in preparing major regulatory filings with the FDA and supportive amendments or supplements
Strong leadership and communication skills, with the ability to guide and collaborate effectively across functions and levels of the organization
Energetic, creative, analytical problem solver who acts independently yet communicates broadly
Strategic thinker with the ability to anticipate and mitigate regulatory risks
Expertise in the current regulatory landscape and evolving guidance

Responsibilities

Direct US regulatory strategies for assigned projects, supporting the global clinical development and lifecycle
Identify and assess regulatory risks associated with product development and define strategies to mitigate these risks
Set strategic direction and lead the US regulatory submission process, including INDs, NDAs, sNDAs and briefing packages
Support the development of the US label and represent US regulatory strategy at global labeling team meetings
Monitor and analyze FDA activities and assess their specific impact on your projects
Foster positive interactions with the FDA
Represent the department in US project teams, committees, and external meetings

Benefits

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