Associate Director, Regulatory Sciences Strategies - United States
|External Posting Title||Associate Director, Regulatory Sciences Strategies|
• Develop and implement global regulatory strategies for early stage assets, initiating prior to R to D transition and continuing through proof of concept. Responsible for establishing regulatory engagement approaches in order to set strategic direction for the early pipeline.
• Identify and assess opportunities for innovative and risk-forward regulatory approaches to support effective and efficient product development. Define strategies to mitigate risks.
• Monitor and analyze regulatory agency activities across areas of interest, assess impact on products and portfolio, and propose strategies to address as required
• Provide strong leadership on project teams in all areas of regulatory science and product development
• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position
• Direct the organization and preparation of clear and effective submissions
• Prepare and deliver effective presentations for external and internal audiences
• Provide input to senior management teams
• Foster a global view as part of a collaborative regulatory team
• Actively participate in and contribute to regulatory policy development
|Location||Cambridge, MA, US|
• 8 years pharmaceutical and biotechnology industry experience. Minimum of 6 years experience in Regulatory Sciences.
• Experience in the interpretation of regulations, guidelines, policy statements, etc.
• Experience and knowledge in preparation of regulatory submissions including but not limited to INDs, IMPDs, meeting requests, and briefing books.
• Experience interfacing with relevant regulatory agencies
• Advanced scientific degree highly preferred. B.S. degree required.
|About Biogen||Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.|
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. With a strong affiliate presence and a network of distribution partners, Biogen has established a global footprint that allows us to capture the greatest value for the products we develop.
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.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
Nearest Major Market: Cambridge
Nearest Secondary Market: Boston
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