Biogen is on a mission to transform patient lives by pioneering and leading in neuroscience.
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. 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). You will also represent the company with domestic and international regulatory authorities, contractors and corporate partners. Additionally, you will provide regulatory support for various departments, projects, and teams/committees.
What You’ll Do:
• You are responsible for directing global regulatory strategies for assigned projects and programs.
• You will have direct responsibility for global clinical and pre-clinical regulatory strategies 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 research and 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 analyze appropriate regulatory agency activities in areas of interest to the company and assess impact on programs.
• You would have the opportunity to mentor Regulatory Managers and guide direct reports in carrying out responsibilities. You will also be responsible for coordinating activities and career development of direct reports.
• 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 part of the whole regulatory team.
B. Additional Functions:
• You take steps to actively improve interdepartmental communications.
• You are an active participant in outside relevant conferences, including organizing and delivering presentations.
• You may have presence on external regulatory committees/trade associations.
Who You Are:
In addition to having exceptional relationship building with the agencies, you 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.
· Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD, MBA).
· 810+ years’ experience in the pharmaceutical industry within R&D, Regulatory or a related function, with at least 5 years working in regulatory affairs.
· Extensive experience working on regulatory aspects of products in development specifically relating to pre-clinical, clinical, and life cycle innovation.
· Expert knowledge with respect to the respective regulatory landscapes in the US, EU, and Japan.
· 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.
· Foster effective, positive interactions with regulatory agencies, and corporate partners.
· Ability to lead and influence project teams, committees, etc. to attain group goals.
· Demonstrate excellent leadership and communication skills.
· Ability to represent the department in project teams, committees and external meetings.
Supervisory/mentoring experience, including ability to guide, train, supervise and prioritize workload of direct reports if applicable.
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.