Executive Director, Global Regulatory Affairs TA Strategy Lead, Neurology

Alexion

Job Description

Position Summary

The Therapeutic Strategy Lead, Global Regulatory Affairs Development Strategy (GRA-DS), will be responsible for developing and implementing regulatory strategies for all assigned products with the intention of achieving successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. This individual will, with a high sense of urgency, lead a team of regulatory professionals to provide operational and strategic regulatory input to cross-functional teams responsible for global programs. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

Principal Responsibilities

  • Manage a team staff at various levels within the therapeutic area (TA) from junior level Specialists to more senior level Directors/Global Regulatory Leads (GRLs), coordinating resourcing and balancing project support across portfolio products within the TA. Supervise regulatory staff to provide leadership and career development input as well as coaching/mentoring support. 
  • Provide strategic oversight for projects in the TA, aligned to overall R&D objectives for the TA from early development, through initial registration and subsequent global expansion, and including implementation of new indications and formulations.
  • Member of the GRA Steering Committee which is an advisory body from which GRA staff can seek insight on strategic and procedural/operational issues as they arise.
  • Actively collaborate with management and cross functional colleagues (including commercial, research, clinical development, medical affairs, business development) within Alexion at the TA level to provide portfolio level regulatory insight and broader drug development expertise.
  • May represent Alexion as point contact with regional health authority and lead Alexion delegation to regulatory meetings.
  • Monitor the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs. Provide support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
  • Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies.

Qualifications

  • Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
  • Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
  • Ability to manage complex issues and coordinate multiple projects simultaneously
  • Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization. 
  • Strong interpersonal, and written/verbal communication skills.
  • Proven track record practicing sound judgment as it relates to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.

Education

  • Bachelor’s Degree in a related discipline     
  • 12+ years in pharmaceutical industry regulatory affairs

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