Associate Director /Director
Biogen
The Associate Director Global Regulatory Strategywill be responsible for developing and delivering innovative breakthrough global and EU regulatory strategies for product development and approval in alignment with the global business strategy. Responsibility of leading the global and EU regulatory strategy for the development of their asset/s. 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). Provide regulatory support for various departments projects and teams/committees.
Responsible for directing global and EU regulatory strategies for assigned projects and programs including supporting development of the CDP and directing global life cycle management.
~ Identify and assess regulatory risks associated with product development. Set strategic direction and leads global regulatory submission process with submission teams including marketing applications and core briefing packages.
You are a confident and collaborative leader with a proven ability to foster productive relationships with regulatory agencies and corporate partners. You thrive in cross-functional environments guiding multidisciplinary teams and project committees toward shared goals. Your excellent communication and interpersonal skills allow you to effectively engage with senior stakeholders across scientific medical and manufacturing domains. With strong organizational acumen you manage complex workloads and competing priorities with ease. You bring a deep sensitivity to multicultural and multinational contexts and have a solid track record of mentoring and supervising others to success.
Higher degree preferred (PharmD MSc PhD MBA).
- Late-stage development regulatory experience preferably including leading a significant submission (eg NDA or BLA MAA). Prior experience as a Global and EU regional regulatory lead in pharma.
- 8 years pharmaceutical/biotechnology industry experience with technical management experience. Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
- Late-stage development regulatory experience preferably including leading a significant submission (eg NDA or BLA MAA).
- Job Level: Management
Director
Die Stellenanzeige wurde vor Vor 12 Tagen veröffentlicht
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