Director/Senior Director, Regulatory Affairs, CMC
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Wilmington, DE 19803
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function)
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.
Essential Functions of the Job (Key responsibilities)
- 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 large molecule (biologics) development programs to worldwide regulatory authorities, 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 global regulatory standards. Provide critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications world-wide. 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 guidance, laws and regulations, and proposed and final rules which affect CMC pharmaceutical and biologic drug development.
- Liaises with other regulatory and operations staff to ensure appropriate project support is provided.
- Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies for biologic products.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- 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/biologic development field. Experience with regulatory CMC aspects of biologics drugs preferred. Experience with global clinical trial and/or marketing applications, eCTD submissions and electronic document management systems is required.
- In-depth knowledge of pharmaceutical and biotechnology drug development, and related global CMC regulations/guidelines is required.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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