Director, Regulatory Affairs CMC

Director, Regulatory Affairs CMCJob Locations US-NJ-ParamusID2026-1944CategoryRegulatory AffairsTypeRegular Full-TimeOverviewA Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products.Responsibilities- Regulatory Submissions:Oversee the preparation and high-quality review of CMC components for major filings, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval supplements. Ensure CMC components in regulatory filings are scientifically sound, compliant, and aligned with ICH, FDA, EMA, and other global guidelines.- Health Authority Interactions:Serve as the primary point of contact for CMC-related negotiations with regulatory agencies, including leading formal meetings and responding to deficiency letters.- Cross-Functional Collaboration: Partner with Quality Assurance, CMC and Clinical Supply, R&D to ensure compliance with cGMP (current Good Manufacturing Practices) and assess the regulatory impact of CMC development plans and manufacturing changes.- Intelligence & Compliance:Monitor the evolving global regulatory landscape and communicate the impact of new guidelines (e.g., ICH guidelines) to senior leadership.- Team Mentorship:Lead, mentor, and develop a team of regulatory professionals, managing resources and project prioritization, as applicable.Supervision Exercised:- May be required to mentor and provide guidance to junior team members.Qualifications- A bachelor's degree in a scientific field (Chemistry, Pharmacy, Biology, or Engineering) is required; an advanced degree (MS, PhD, or PharmD) is highly preferred.- Requires 10-15+ yearsin the pharmaceutical industry, with at least 8-10 years specifically focused on CMC regulatory affairs- Deep expertise in eCTDsubmission formats, global regulatory requirements (US, EU, and Canada), and a proven track record of successful marketing application approvals.- Strong negotiation, conflict management, and the ability to influence cross-functional teams without direct authority.- Expertise with multiple dosage forms for small molecule drugs is preferred- Experience with biologics is a plus.- Ability to travel up to 20% of the time domestically and internationally- Experience working with VeevaAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Created: 2026-02-20