About This Role
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.
What You’ll Do
- 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
Who You Are
You thrive in collaborative settings, advocating for your department's interests while promoting shared objectives. You possess strong leadership and communication skills, enabling you to effectively help guide project teams. Your organizational skills are exceptional, allowing you to prioritize workloads and manage multiple tasks efficiently. Your multicultural sensitivity and ability to navigate a multinational environment make you an asset to our team.
Required Skills
- 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
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.
Biogen Cambridge, Massachusetts, USA Office
225 Binney Street, Cambridge, MA, United States, 02142
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