Assoc Dir/Sr Dir, Strategic Regulatory Consulting (Remote US)

Company: PPD
Location: Phoenix
Posted on: June 26, 2022

Job Description:

Job Description

The Assoc Director/Sr Director, Strategic Regulatory Consulting 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.
• Reviewing and interpreting regulatory precedents and benchmarking to inform development strategies.
• Acting as a regulatory Subject Matter Expert (SME) work with cross function 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.
• Identifying and executing on opportunities for products and clients to benefit from facilitated regulatory pathways such as ODD, Breakthrough, PRIME, ILAP etc
• Providing regulatory oversight across programs and portfolios.
• Providing senior level strategic direction, review, oversight and governance that compliments and supports the strengths of the wider Regulatory Affairs group in relation to regulatory procedures and preparations including designations, agency meetings, INDs/CTAs, NDA/BLA/MAA (particularly around development of Module 2, ISE/ISS and key licensing messaging).
• 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 and 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.
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  Job Qualification
  
  Requirements
  
  • At least 10 years Strategic Regulatory Experience in the pharmaceutical industry with a demonstrable record of career advancement and drug development accomplishments
  • A focus in several therapeutic areas, oncology and/or rare diseases highly desirable and tangible achievements in other therapeutic areas
  • Significant knowledge of, and experience with US 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 write regulatory submissions from source documents.
  • Ability to manage multiple projects, co-ordinate with Subject Matter Experts and lead discussions with clients.
  • Demonstrated understanding of the drug development process.
  • Advanced degree (PhD, PharmD, MD, MS) is desirable, although emphasis is on experience.
  • Experience as a consultant desired but not required.
  • Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams.
    

Keywords: PPD, Phoenix , Assoc Dir/Sr Dir, Strategic Regulatory Consulting (Remote US), Professions , Phoenix, Arizona