- 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.
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