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Job #03118

About our client Our client is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life- threatening and debilitating diseases including cancer, inflammation, autoimmune and infectious diseases. Position Location Regulatory Product Manager Bloomsbury, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee regulatory strategy for the product development program 2) Ensure early identification of major regulatory issues/threats affecting the development of global products and identify corrective regulatory action 3) Oversee all US and Canadian INDs and European clinical trial applications (CTA) for a given product (including initial submission and new protocols, protocol amendments, Serious Adverse Event (SAE) reports, Investigator information and IND/CTA annual reports) 4) Prepare and manage approval of regulatory documents for submission to global health authorities (US and EU Orphan Drug Applications, Fast Track Designation Applications, USAN applications and IMPDs for CTA applications) 5) Prepare all cover letters for regulatory submission 6) Draft health authority meeting and teleconference minutes 7) Maintain primary contact with health authorities 8) Arrange teleconferences and meetings with all regulatory agencies 9) Manage the company's preparation for interactions with regulatory agencies 10) Maintain HHS database Clinicaltrials.com 11) Prepare and submit Regulatory Affair’s health authority submissions Requirements 1) BS in Science 2) Minimum 3 – 5 years of US and EU product development regulatory affairs experience (for drugs and biologics) 3) Experience in clinical and pre-clinical pharmaceutical industries 4) Team meeting experience 5) Good communication and writing skills 6) Ability to adapt to changing projects and deadlines 7) Well-organized and detail-oriented