Duties and Responsibilities
- Ensures regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
- In alignment with RA-CMC leader, supports / manages regulatory CMC strategy and submission aspects for both small and large molecule development programs.
- Provides critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications.
- Ensures regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent and complete.
- Participates in and supports / manages post-approval global product activities such as, but not limited to, change control, product complaints, marketing application supplements and variations.
- Works with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
- Participates in meetings with internal and external partners or teams for clinical development programs or collaborations, in order to communicate regulatory CMC guidance and strategies.
- Liaises health authorities as needed (e.g. telephone contacts, submissions). Participate in regulatory CMC related health authority meetings for assigned projects. Prepare summaries of meetings and contacts for inclusion in the regulatory archives.
- Maintains current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
- Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
Requirements
- BA/BS degree is required. Advanced degree (M.S., Ph.D or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field desirable.
- A minimum of 3 year of experience in regulatory affairs CMC or a related pharmaceutical development field. Experience with regulatory CMC aspects of both large and small molecule drugs preferred. Experience with global clinical trial and marketing applications, eCTD submissions and electronic document management systems.
- Good knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals and/or biotechnology products.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
