Head of Regulatory Affairs

Role overview

Eurofarma is seeking an experienced Head of Regulatory Affairs & CMC for its U.S. headquarters in Parsippany, New Jersey. This full-time, exempt, at-will position is responsible for leading all regulatory affairs activity in the United States, with particular emphasis on FDA engagement and CMC strategy across the full product lifecycle. The role is designed for a senior regulatory professional who can balance high-level planning with hands-on execution to support compliance, business continuity, and growth in the U.S. market.

The successful candidate will serve as the main point of contact with the FDA and will contribute directly to product development, commercialization, post-approval work, and oversight of external manufacturing partners. The role reports to the General Manager.

Regulatory affairs and CMC leadership

• Own and prepare U.S. regulatory filings such as INDs, NDAs, ANDAs, supplements, amendments, annual reports, and PADERs.
• Build and implement CMC regulatory plans spanning development, launch, and lifecycle maintenance.
• Assess and sign off on labeling-related regulatory submissions in partnership with internal stakeholders.
• Evaluate CMC change controls and determine the most appropriate filing approach from a regulatory perspective.
• Track updates in FDA rules and guidance and translate them into practical direction for internal teams.

FDA and health authority engagement

• Serve as the primary regulatory contact for the FDA and any other relevant authorities.
• Plan, lead, and support FDA inspections, including pre-approval and CMC-focused inspections.
• Handle regulatory communications and ensure responses are accurate, timely, and compliant.
• Oversee completion of all U.S. regulatory commitments and post-approval obligations.

Cross-functional and external partnership

• Work closely with R&D, Manufacturing, Quality, Supply Chain, Pharmacovigilance, and Commercial teams across local and global functions.
• Provide regulatory support for product transfers to CMOs.
• Assess and approve suppliers, CMOs, laboratories, and technical partners from a U.S. regulatory standpoint.
• Coordinate CMC documentation and ensure regulatory readiness with outside partners.

Leadership and decision support

• Manage and grow a small Regulatory Affairs team based in the U.S.
• Deliver regulatory risk assessments and strategic recommendations to senior leadership.

Experience and profile

This position calls for a strong scientific background and substantial U.S. pharmaceutical regulatory experience, especially in CMC. The ideal candidate will bring extensive direct experience with FDA submissions and interactions, plus practical exposure to CMOs and external vendors. Strong judgment, a detail-oriented approach, and the ability to execute effectively are essential.

Employment details

Employment type: Full-time.

Work arrangement: Onsite.

Employment status: Exempt, at-will.

Location: Parsippany, New Jersey, United States.

Reporting line: General Manager.

Qualifications

• A bachelor’s degree or above in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or a related scientific discipline.
• At least 10 years of experience in U.S. pharmaceutical Regulatory Affairs, with a strong CMC focus.
• Hands-on background in FDA submissions and direct interaction with the FDA.
• Experience working with Contract Manufacturing Organizations and external suppliers or vendors.
• Strong understanding of FDA regulations, labeling requirements, and CMC expectations.
• Sound strategic thinking, solid execution skills, and close attention to detail.