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.
#PPDHP
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
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