Senior Manager, Regulatory Affairs CMC - United States
- Ensure 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, manage regulatory CMC strategy and submission aspects for both small and large molecule development programs.
- Provide critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications.
- Ensure regulatory CMC submissions comply with current regulatory standards, are of high quality, consistent and complete.
- Participate in and manage post-approval global product activities such as, but not limited to, change control, product complaints, supplements and variations.
- Work with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
- Participate in meetings with internal and external partners or teams for clinical development programs or collaborations, in order to communicate regulatory CMC guidance and strategies.
- Liaise with FDA and other 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.
- Maintain current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
- Participate in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
- BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- A minimum of 3 years 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, highly desirable.
- In-depth knowledge of pharmaceutical drug development, and CMC regulations/ guidelines governing development of pharmaceuticals.