Job Description

About this role
The Associate Director, Global Regulatory Strategy will be responsible for developing and delivering innovative, breakthrough global and EU regulatory strategies for product development and approval, in alignment with the global business strategy. Responsibility of leading the global and EU regulatory strategy for the development of their asset/s. 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). Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.
Your responsibilities

• Responsible for directing global and EU regulatory strategies for assigned projects and programs, including supporting development of the CDP and directing global life cycle management.

• Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.

• Set strategic direction and leads global regulatory submission process with submission teams, including marketing applications and core briefing packages.

• Support the development of Core Data Sheet and SmPC and representing regulatory strategy at global labeling team meetings.
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on programs.

Who you are
You are a confident and collaborative leader with a proven ability to foster productive relationships with regulatory agencies and corporate partners. You thrive in cross-functional environments, guiding multidisciplinary teams and project committees toward shared goals. Your excellent communication and interpersonal skills allow you to effectively engage with senior stakeholders across scientific, medical, and manufacturing domains. With strong organizational acumen, you manage complex workloads and competing priorities with ease. You bring a deep sensitivity to multicultural and multinational contexts and have a solid track record of mentoring and supervising others to success.
Required skills

• Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD, MBA).
• Late-stage development regulatory experience, preferably including leading a significant submission (eg NDA or BLA, MAA). Prior experience as a Global and EU regional regulatory lead in pharma.
• 8 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 6 years in Regulatory Affairs (Strategy).
• Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
• Late-stage development regulatory experience, preferably including leading a significant submission (eg NDA or BLA, MAA).
• Direct experience in interfacing with relevant regulatory authorities (FDA, EMA, and PMDA).
• Experience in interpretation of regulations, guidelines, policy statements, etc.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

Job Level: Management
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. 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.