Director Regulatory Affairs (CMC)

Job Description

Job Description

Our Pharmaceutical client is seeking a Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants.

• Plan, prepare, and critically review CMC components of regulatory documents including INDs, Annual Reports/DSURs, Amendments, Comparability Protocols and Evaluation Packages, BLAs, NDAs, DMFs, Meeting Briefing Packages, SPA, IBs, and equivalent documents of other countries’ health authorities without supervision. Respond in a timely manner to deficiency questions and inquiries from health authorities. Collaborate with project team representatives to ensure those documents meet regulatory requirements/guidance, and ensure clear communication of risks to the executive management.
• Lead all RA-CMC operations through all phases of clinical development; from FIH through post-approval maintenance.
• Communicate and collaborate with global counterparts effectively, ensuring alignment.
• Mentor lower-level members in RA and RA-CMC in lifecycle regulatory-CMC and eCTD strategy.
• Lead and/or participate in process improvement initiatives between business entities.
• Lead the CMC aspects of Health Authority meetings.
• Responsible as a back up to the Head of Regulatory CMC.

• MS Degree required with 15+ years of related experience in the pharmaceutical or biopharmaceutical industry
• Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to CMC.
• Good working knowledge of Microsoft Office required.
• Prior experience with authoring, submission, and approval process of a major marketing application
• Prior experience with assessing change controls and the preparation of post-approval supplements
• Experience with primary authoring of all drug substance and drug product sections
• Cultural sensitivity is essential and the ability to develop consensus within a multinational organization necessary.
• Broad level of interpersonal skills, leadership ability and flexibility also necessary.
• Excellent collaboration skills needed.
• Excellent problem-solving skills also needed.