Head of Regulatory Affairs

Head of Regulatory Affairs – Eurofarma Inc.Location: Parsippany, New Jersey (US Headquarters)Employment Type: Full-time | Exempt | At‑will employmentReports to: General ManagerRole OverviewThe Head of Regulatory Affairs & CMC (US) will lead all U.S. regulatory affairs activities, with a strong focus on FDA interactions and CMC regulatory strategy across the product lifecycle. This role requires a highly experienced, hands‑on regulatory leader who can combine strategic oversight with execution, ensuring regulatory compliance while enabling business continuity and growth in the U.S. market.The position serves as the primary interface with the FDA and plays a critical role in supporting product development, commercialization, post‑approval activities, and oversight of external manufacturing partners.Key ResponsibilitiesRegulatory Affairs & CMCLead and author U.S. regulatory submissions, including INDs, NDAs, ANDAs, supplements, amendments, annual reports, and PADERs.Define and execute CMC regulatory strategies across development, commercialization, and lifecycle management.Review and approve regulatory aspects of product labeling submissions in coordination with internal stakeholders.Review and approve CMC change controls and define appropriate regulatory filing strategies.Monitor evolving FDA regulations and provide clear regulatory guidance to internal teams.FDA & Health Authority InterfaceAct as the primary liaison with the FDA and other applicable regulatory authorities.Lead and host FDA inspections, including pre‑approval and CMC‑related inspections.Manage regulatory correspondence and ensure timely and compliant responses.Ensure fulfillment of all U.S. regulatory commitments and post‑approval obligations.Cross‑functional & External CollaborationPartner closely with R&D, Manufacturing, Quality, Supply Chain, Pharmacovigilance, and Commercial teams, both local and corporate. Support product transfers to Contract Manufacturing Organizations (CMOs) from a regulatory perspective.Vet and qualify suppliers, CMOs, laboratories, and technical partners from a U.S. regulatory standpoint.Coordinate CMC documentation and regulatory readiness with external partners.LeadershipLead and develop a small U.S.‑based Regulatory Affairs team.Provide regulatory risk assessments and strategic input to senior leadership.Experience & ProfileBachelor’s degree or higher in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related scientific field.Minimum 10 years of experience in U.S. pharmaceutical Regulatory Affairs, with strong emphasis on CMC.Extensive hands‑on experience with FDA submissions and direct FDA interactions.Proven experience working with Contract Manufacturing Organizations and external vendors.Deep knowledge of FDA regulations, labeling requirements, and CMC expectations.Strong strategic judgment, execution capability, and attention to detail.