Assoc Dir/Sr Director, Strategic Regulatory Consulting (Remote)
Posted on: May 15, 2022
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
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
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
Engage in and execute thought leadership initiatives supporting and
showcasing Strategic Regulatory Consulting and the wider
Maintenance of up-to-date knowledge and understanding of PPD SOPs,
relevant client SOPs/directives, and current regulatory guidelines
as applicable to services provided.
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
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, Miami , Assoc Dir/Sr Director, Strategic Regulatory Consulting (Remote), Executive , Miami, Florida
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