Regulatory Associate Program Director
Location: San Francisco Bay Area
Regulatory Associate Program Director | Global Biotech Company
This search is being conducted on behalf of our leading biotechnology client. They have multiple products on the market and over 45 molecules in the development.
As the Regulatory Associate Program Director, you will interpret the needs of worldwide health authorities while providing the regulatory expertise to drive product development from early development to post-marketing. You will take the lead for assigned projects and represent PDR to cross-functional teams and serve as the principal interface with health authorities, managing the strategies for and execution of these interactions.
HIGHLIGHTS OF RESPONSIBILITIES:
Plays a key role in creating innovative long-range strategies to expedite development of our projects in immunology, infectious disease, ophthalmology, or neuroscience therapeutic areas from first-in-human through lifecycle management.
Develops regulatory strategies with global cross functional clinical, non-clinical and business development teams. Provides project teams with leadership regarding regulatory authority interactions.
As the US regulatory subject matter expert, leads the US Regulatory strategy as a member of a global Regulatory Affairs Functional Team for assigned development projects. Serves as the primary regulatory representative on one or more regional or global projects.
Acts as primary liaison and manages a professional relationship between the FDA and project teams for assigned projects.
Responsible for timely and high-quality regulatory submissions for INDs,BLAs/NDAs, and supplement applications to the FDA.
DESIRED SKILLS AND QUALIFICATIONS:
Bachelor’s Degree required (life sciences disciplines strongly preferred).
5+ years of relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing. Experience participating in global product development teams is preferred.
Experience as a regulatory contributor for global original IND/NDA/BLA filings in the US is preferred.
Broad understanding of US FDA regulations, processes and issues in drug/biologics development. Includes in-depth knowledge of GCP and ICH.
To learn more about this opportunity, contact a member of our team at 267-483-5233 or firstname.lastname@example.org.
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Suite 2B
Warrington, PA 18976