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Regulatory Affairs Lead

Company: FPC of Atlanta
Location: Raleigh
Posted on: February 24, 2021

Job Description:

Clinical and Drug Development focused (and not CMC)Exciting large molecule and small molecule Pharmaceutical company seeks Clinical and drug development focused Regulatory Affairs Lead for responsibilities including the below:* Regulatory Strategy development across multiple indications. Multiple Therapeutic areas may also be focused on.* Oversee domestic regulatory strategy while also participating in international (especially) regulatory strategies across indications.* Work cross functionally with regulatory teammates as well as with Clinical, Pharmacology, Labeling, Product Development, and Marketing professionals* Advise Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.* Represent company to Regulators (including the FDA)* Manage regulatory submissions. These can include IND, BLA and NDA * Review Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators' Brochures and Briefing Packages.* Investigational New Drug application/Clinical Services Agreement review* Identify possible regulatory risks and determine mitigation strategies and options* Regulatory due diligence activities for licensing candidate review.Location note:--Besides Raleigh, NC this could also be based in multiple other East Coast locations.--Relocation support package available?Requirements* Bachelor's Degree or higher.--Scientific discipline preferred.* 4+ years of Regulatory Affairs experience* Drug Development and/or Clinical experience* Regulatory supplement experience * Regulatory communications experience

Keywords: FPC of Atlanta, Raleigh , Regulatory Affairs Lead, Other , Raleigh, North Carolina

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