Manager, Global Regulatory Affairs
Found in: Resume Library US A2 - 2 weeks ago
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 appropriate
Effectively coordinate with the Submission Operations group to ensure on-time preparation and publishing of regulatory submission documents
Ensure regulatory documentation is maintained appropriately
Provide 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.
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