About this role:

As the Global Regulatory Lead, you will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. In this role, you will use your experience to help lead the program and regulatory teams through innovative lifecycle management initiatives for a marketed product in a pediatric rare neuromuscular disease.  You will be 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). If assigned programs that are pre-proof of concept, this role also acts as the US Regulatory lead for that assigned program.  In this case, you will represent the company to the FDA as well as to contractors and corporate partners. Additionally, you may provide ad-hoc regulatory support to other departments (ie., Digital Health, Medical Device), projects, and teams/committees.

What You’ll Do:

• You are responsible for directing global regulatory strategies for assigned projects and programs. One of these programs will be a highly active marketed product and you may also be responsible for another program, likely to be in early development
• You will have direct global clinical regulatory strategy and global life cycle management of products.
• You will identify and assess regulatory risks associated with product development and define strategies to mitigate risks.
• You will provide regulatory guidance to company personnel throughout the development process.
• You will set strategic direction and lead the global regulatory submission process with the submission teams, including marketing applications and core briefing packages.
• You will advise on global CTA submission strategy.
• You will direct the organization and preparation of clear and effective submissions.

• You will Prepare and deliver effective presentations for external and internal audience.
• You may monitor and analyse appropriate regulatory agency activities in areas of interest to the company and assess impact on programs.
• You will build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
• You would be able to provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
• You will maintain a global view as leader of the Regulatory Program Team.
 

Who You Are:

You have successfully worked in a matrix environment where you collaborated with other teams within the organization. You have strong Global Regulatory experience along with strong teamwork capabilities, are comfortable working in a fast-paced environment and excited by the opportunity to work in a disease area of unmet need.

Required Skills

·       Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD, MBA).

·       8+ years’ experience in the pharmaceutical industry within Regulatory or a closely-related function.

·       Extensive experience working on regulatory aspects of products in development specifically relating to clinical, and life cycle innovation.

·        Expert knowledge with respect to the regulatory landscapes in the US, EU, and Japan.

·       Experience in interpretation of regulations, guidelines, policy statements, etc.

·       Experience and knowledge in the preparation of meeting packages, initial INDs, and supportive amendments or supplements.

·       Foster effective, positive interactions with cross functional stakeholders and corporate partners.

·       Ability to lead and influence project teams and committees to attain group goals.

·       Demonstrate excellent leadership and communication skills.

·       Ability to represent the department in project teams, committees, and external meetings.

Why Biogen?  

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.   

The base compensation range for this role is 174,000 to $291,000. 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.