Director, Regulatory, CMC

Position Title: Director, Regulatory, CMCReports to: ED, Regulatory AffairsLocation: Hybrid, Princeton, NJ PMV is seeking an experienced and motivated Director of Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) to lead the development and execution of CMC regulatory strategy for the Company's assets. The Director, Regulatory Affairs-CMC will work closely with cross-functional teams, including other Regulatory functions, CMC, Quality Assurance, and external vendors) to ensure the successful submission of CMC dossiers and compliance with regulatory guidelines across regions throughout the product lifecycle.Responsibilities Act as Regulatory CMC Lead: Serve as the primary interface between CMC subject matter experts (SMEs) and Regulatory Affairs. Coordinate and lead all CMC regulatory projects, including budget, timelines, and CMC submission planning, ensuring all deliverables are met on time and within scope. Manage Regulatory CMC contractors/consultants to ensure activities are completed according to budget and timelines.Global Regulatory CMC Strategies: Develop and align global regulatory CMC strategies with overall product development plans and company goals. Assess proposed manufacturing process changes and provide strategic regulatory guidance for global implementation.Regulatory Authority Contact for CMC Topics: Act as the Regulatory CMC contact with regulatory authorities. Plan, prepare, and lead strategic CMC-related health authority meetings.Regulatory CMC Submissions: Independently plan, execute, and manage CMC submissions and responses to CMC-related Agency queries for assigned compounds in various phases of clinical development, global marketing applications, and post-approval activities. Ensure all documentation meets regulatory standards and timelines.Risk Management: Identify and mitigate potential regulatory risks related to CMC.Quality and Compliance: Ensure CMC activities comply with relevant regulatory guidelines (FDA, EMA, ICH, etc.). Monitor and interpret evolving regulatory guidelines and trends, ensuring the company's CMC strategies remain current and compliant. Provide regulatory support for quality systems such as change control and inspection management. Support interactions with regulatory agencies during inspections.Collaboration: Work with CMC, Quality, other departments, CMOs, the EU QP, and external vendors to integrate CMC regulatory strategies into overall product development plans. Provide CMC-related regulatory guidance to other functional areas, including Manufacturing and Quality, throughout the product lifecycle. Stakeholder Communication: Ensure project team colleagues, line management, and key stakeholders are informed of developments that may impact regulatory success.QualificationsBachelor's degree in scientific discipline required (chemistry preferred); Master's or Ph.D. preferred.Minimum of 8 years of industry experience in regulatory affairs CMC. Experience with small molecule solid dosage forms is required and oncology products is highly desirable. In-depth knowledge of global CMC regulatory requirements and guidelines (FDA, EMA, ICH, etc.). Considerable experience with CMC development, process validation, comparability protocols, amendments, and supplements.Proven ability to liaise with Regulatory Agencies, having led successful Agency Interactions related to CMC submissions. Proven track record of successful CMC submissions for INDs, NDAs/BLAs, and other regulatory filings. Experience with producing CMC sections from early development to pre- and post-approval submissions (e.g., INDs/NDAs/MAAs/Annual Reports/IMPDs) and familiarity with eCTD structure and granularity requirements.Preference for experience managing Regulatory CMC contractors/consultants.Project Management: Ability to manage complex projects with independent decision-making and analytical thinking skills. Strong project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.Communication Skills: Excellent written and verbal communication skills. Ability to effectively communicate complex technical information to regulatory authorities, senior management, and cross-functional teams.Adaptability: Ability to thrive in a fast-paced, dynamic environment and manage changing priorities.PMV provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.

Created: 2025-01-27