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Executive Director Regulatory Strategy

Pharmaceutical Product Development (PPD)

Multiple locations

The Executive Director Regulatory Strategywithin the strategic development consulting department will be responsible for advising clients on strategic regulatory considerations for products in development including: 

  • Defining regulatory pathways and strategies for optimized product development pathways.
  • Acting as a regulatory subject matter expert (SME) working with cross-functional teams to contribute to the development of target product profiles, strategic program assessments, clinical development plans and integrated development plans. 
  • Defining critical regulatory milestones and messaging to facilitate approvable investigational and marketing applications to regulatory agencies. 
  • Work on problems of diverse scope where analysis of data requires in-depth evaluation of identifiable factors.
  • Providing regulatory oversight across programs and portfolios.
  • Provide senior-level strategic direction to the strategic development consulting team on ways to optimize work processes for delivering consulting services and creating new client offerings.
  • Providing and facilitating an expert-level interface between regulatory agencies and client.
  • Representing the strategic regulatory consulting group in discussions with clients and building relationships.
  • Participate and contribute to the strategic regulatory consulting team, its development and growth.
  • Take an active role in business development to expand the portfolio of both standalone regulatory and cross-functional consulting projects.
  • Engage in and execute thought leadership initiatives supporting and showcasing strategic regulatory consulting and the wider organization.
  • Maintenance of up-to-date knowledge and understanding of PPD SOPs, relevant client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Recruit and lead senior-level strategic regulatory consultants to build out the regulatory strategy team.
  • Bachelor's or advanced degree (PhD, PharmD, MD, MS), although emphasis is on experience.
  • At least 15 years of product development/strategic regulatory experience in the pharmaceutical industry with a demonstrable record of career advancement and drug development accomplishments 
  • Significant knowledge of, and experience with U.S. Phase I - III regulatory requirements with a proven track record for successful negotiations with health authorities. Wider global regulatory knowledge, particularly in APAC, is an advantage.
  • Ability to manage multiple projects, co-ordinate with SMEs and lead discussions with clients.
  • Subject matter expertise in development and regulatory strategies for advanced cellular and gene therapy products and biologics is preferred. 
  • Demonstrated understanding of the entire drug development process is required.
  • Advanced degree (PhD, PharmD, MD, MS) in a science related field (Chemistry, Cellular or Molecular Biology, Pharmaceutics or Process Engineering) preferred.
  • Experience as a consultant is required.
  • Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams.

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Ability to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • May require travel.  (Recruiter will provide more details.)

Job posted: 2023-02-27

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