This is a remote-based position, candidate must be located within the USA

About This Role

The Associate Director, Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities (including US, EU, JP, and China). They will represent the company with domestic and international regulatory authorities, contractors and corporate partners and provide regulatory support for various departments, projects, and teams/committees. Over time, may manage direct reports.

What You’ll Do

• Responsible for developing and executing global regulatory strategies for assigned projects and programs.
• Support development of the preclinical and clinical development plan.
• Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies.
• Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages.
• Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA.
• Mentor Regulatory Managers.
• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
• Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
• Provide input to Senior Management teams.
• Maintain a global view as part of the whole regulatory team.

Required Skills

• BA/BS/University degree, Life/Health Sciences preferred.
• 8 years pharmaceutical/biotechnology industry experience with technical management experience.
• Minimum of 6 years of experience in Regulatory Affairs.
• Comprehensive knowledge of applicable regulations.
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Expertise and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
• Knowledge of regulations governing the development of drugs.
• Solid knowledge of GCPs and GLPs.
• Direct experience in interfacing with relevant regulatory authorities (FDA).
• Demonstrated excellent leadership and communication skills, inclusive of supervisory/mentoring experience, and ability to lead project teams.
• Strong organizational skills, including the ability to prioritize personal workload.
• Excellent interpersonal skills and the ability to communicate effectively with a variety of senior personnel including medical, scientific, and manufacturing staff.

Preferred Skills:

• Graduate degree.
• Some international regulatory experience preferred.
• Experience with biologics preferred.
• Expert knowledge and experience in gene therapy highly desirable.

Job Level: Management

Additional Information:

The base compensation range for this role is: $144,000.00-$206,000.00
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:

• 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.