Regulatory Affairs Director

4 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time
Job Title: Associate Director, Regulatory Affairs

AbbVie is seeking an experienced Associate Director to lead our Regulatory Affairs team in Neuroscience. As a key member of our Europe team, you will be responsible for defining and implementing regulatory strategies and deliverables for early and late development compounds and marketed products.

Key Responsibilities:
  • Develop and implement regulatory strategies and deliverables for early and late development compounds and marketed products in Neuroscience.
  • Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is considered at the GRPT, LRST, and other appropriate forums.
  • Effectively lead planning, preparation, and delivery of complex submissions/development programmes from a regional perspective working in a matrix leadership environment.
  • Assess scientific data provided by specialist units for development activities, e.g., scientific advice, special designations, and registration purposes against Europe regulatory requirements, identifying gaps and developing mitigation strategies.
  • Develop a Local Regulatory Strategic Plan in collaboration with the RA personnel in the affiliates to elaborate the region's position on specific projects.
  • Primary RA interface with Europe Market Access and Medical Affairs for early touch points and represent RA in Area Brand Team (ABT) as applicable to provide strategic input for regulatory approval, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations.
Qualifications:
  • Extensive pharmaceutical industry experience in Regulatory Affairs or R&D, with experience in designing, implementing, and leading RA strategy and Agency interaction for development (in activities pertinent to early stage through to late-stage development projects) and life cycle management for the Europe region.
  • Experience working in more than one therapy area with experience in neuroscience desirable but not essential.
  • Experience in leadership of complex programmes with matrix reporting.
  • Recent experience of managing agency meetings.
  • Experience working effectively across cultures and in complex matrixed environments.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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