Director, RA Global Regulatory Strategy

The Director Regulatory Affairs Global Regulatory Lead (Grade 21) in Global Product Strategy is responsible for developing and implementing global, US and Canadian regulatory strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT), ensures strategic messaging in global, US and Canadian regulatory dossiers under guidance of management. Manages compounds through all phases of development, post approval and life cycle of the product. Manages products and change control in compliance with regulations, company policies and procedures. Delivers global, US and Canadian regulatory product strategies to ADT. Demonstrates leadership behaviors consistent with level. May participate in initiatives.


Key Responsibilities Include:

• Leads a team of regulatory professionals who develop strategy for development and marketed products. Ensures inclusion of strategic messaging in the content of global regulatory dossiers. Seeks expert advice and technical support when necessary from Director and TAH level personnel.
• Leads preparation and maintenance of global, US and Canadian regulatory product strategies. Under guidance of supervisor, leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products.
• May participate in regulatory and Company initiatives and contributes to the performance management for other Regulatory Affairs team members.
• Influences the development of regulations and guidance. Analyzes legislation, regulation and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Under supervision, advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department.
• Under direction of supervisor, provides executive management with meaningful regulatory measurements and regulatory opinion.
• Works with GRPT to develop, communicate goals that are in alignment with the business goals. Under supervision of a Director level GRL or TA Head, communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management.
• Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
• Follows budget allocations and keeps supervisor informed on project resourcing.

• Required Education:
  Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).
• Preferred Education:
  Relevant advanced degree is preferred. Certification a plus
• Required Experience:
  5+ years of regulatory experience. Some portion may include relevant exposure to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US&C region.
  Proven 3-5 years in a leadership role with strong management skills.
• Experience working in a complex and matrix environment, and with multiple stakeholders.
  Experience interfacing with government regulatory agencies. Experience working with Health Authority
• Strong communication and proactive negotiation skills. Business acumen and able to work under pressure
• Preferred Experience:
  7+ years' experience in pharmaceutical regulatory activities; preferably in at least 2 regions/major countries.
  Experience developing and implementing successful global regulatory strategies.
  Strong clinical foundation preferred.

Note: Higher education may compensate for years of experience


Equal Opportunity Employer Minorities/Women/Veterans/Disabled