Manager, Global Regulatory Affairs
📋 Role Overview & Responsibilities
Job Description
Manager, Global Regulatory Affairs
About This Role
The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products. You are a member of the Regulatory Project Team for assigned programs and work with direction from regional or global regulatory leads to accomplish a variety of regulatory activities and deliverables including interfacing with the regulatory operations team.
What You’ll Do
Working closely with, and with direction from regional or global regulatory leads, support execution of regulatory strategy, including working closely with the Regulatory team and cross-functional development teams to prepare submission plans (e.g., submission content plan and timeline) for the creation of document packages for regulatory submissions and management of document package preparation, inclusive of new INDs, CTA, NDA/BLAs, MAA, variations.Assist in the preparation for meetings with global health authorities, inclusive of support for briefing book development, and participate in the leadership of these meetings as appropriateEffectively coordinate with the Submission Operations group to ensure on-time preparation and publishing of regulatory submission documentsEnsure regulatory documentation is maintained appropriatelyProvide support for product labeling, Health Authority Information Requests, Annual Reports, Proprietary name submissions, among other regulatory document types
Who You Are
You are a college graduate with a Bachelor of Science degree in a scientific discipline. You are a Regulatory professional with a minimum of 2 years pharmaceutical industry experience in regulatory affairs, with other functional areas taken into consideration.
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.
Qualifications
Required Skills
BS degree in a scientific disciplineKnowledge and understanding of applicable regulationsExcellent operational skills including planning, organizing and ability to motivate othersAbility to represent the department in project teamsDevelops collaborative relationships to facilitate the accomplishment of work goalsGenerates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunitiesCan build networks to obtain cooperation without relying on authority
Additional Information
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.
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.
Frequently Asked Questions
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This position is located in Cambridge, MA with potential relocation and sponsorship assistance depending on candidate qualifications.
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