Job Description

About This Role:
HI-Bio, Inc., a Biogen company is seeking a Global Regulatory Affairs Lead, where you'll spearhead global regulatory strategies for our immunology portfolio. With your deep knowledge in regulatory affairs and swift adaptability, you'll be pivotal in leading global regulatory filings. The success in this role enhances the company's ability to deliver innovative treatments and solidifies our standing in the biotechnology field. Within our organizational structure, you will be at the forefront of managing regulatory processes that are critical to our mission.

What You’ll Do:

• Lead regulatory strategy design and implementation for development programs, providing strategic regulatory guidance.
• Collaborate globally to define regulatory pathways and ensure alignment with company objectives.
• Manage regulatory submissions, maintaining compliance with regulations and guidelines.
• Establish and nurture relationships with regulatory agencies, acting as the primary regulatory contact.
• Engage with global health authorities to facilitate successful submissions and approvals.
• Identify and mitigate regulatory risks, ensuring ethical conduct and integrity.
• Stay abreast of regulatory changes, informing strategy and decision-making.
• Support regulatory aspects of clinical trials from start-up to completion.
• Author regulatory documents and represent the company in external regulatory matters.
• Direct timelines for regulatory filings to meet project deadlines.
• Develop and review departmental procedures to ensure internal regulatory compliance.
• Influence the external regulatory environment through active industry participation.

Who You Are: You're a strategic thinker with a robust background in regulatory affairs, especially within the immunology field. Your ability to navigate complex regulatory landscapes and lead with integrity makes you an ideal candidate for driving our immunology portfolio's success.

Qualifications

Required Skills:

• Advanced degree (MS, PhD, or PharmD) in life sciences or related field
• 8+ years’ experience in the pharmaceutical industry within R&D, Regulatory or a related function, with at least 5 years working in regulatory affairs
• Comprehensive regulatory knowledge across various regions (US, Canada, EU, Japan) and therapeutic areas.
• Proven track record of strategic planning and execution within the regulatory framework from INDs through NDA/BLA submissions.
• Exceptional leadership and collaboration skills, with the capacity to influence across all organizational levels.
• Independent, energetic, creative analytical thinker and problem solver.
• Strategic foresight with adeptness at anticipating and mitigating risks.
• Up-to-date with regulatory guidelines and landscape changes pertinent to BLAs and other therapeutic programs.
• Superb oral and written communication abilities.

The base compensation range for this role is $180,000 - $300,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

#LTD-1

Additional Information

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.