The Director, Regulatory Affairs, CMC will primarily be responsible for leading CMC regulatory strategy development/execution and regulatory submission management for early development through late-stage (phase 3, registration, post-approval) programs, including both small molecules and large molecule monoclonal antibodies.
location: Wilmington, Delaware
job type: Permanent
salary: $200,000 - 230,000 per year
work hours: 9 to 5
- Ensures compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
- Leads or manages regulatory CMC strategy and submission aspects for both small and large molecule development programs, as assigned.
- Leads or participates in meetings with internal stakeholders and external business partners or teams for clinical development programs or collaborations, in order to communicate regulatory CMC guidance and strategies.
- Ensures regulatory CMC submissions are of high quality, consistent and complete, and comply with current regulatory standards. Provide critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications. Work with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
- Liaises with FDA and other health authorities as needed (e.g. telephone contacts, submissions). Lead regulatory CMC related health authority meetings for assigned projects. Prepare summaries of meetings and contacts for inclusion in the regulatory archives.
- Participates in and manages post-approval global product activities such as, but not limited to, change control, product complaints, supplements and variations.
- May provide regulatory CMC leadership for due diligence activities and product/company integrations.
- 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.
- BA/BS degree is required. Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field preferred.
- A minimum of 8-10 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 and biotechnology drug development, and related global CMC regulations/guidelines.
skills: CMC, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.