Associate Director, CMC Regulatory Affairs
Janssen Research & Development, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director, Global Regulatory Affairs – CMC with a focus on Vaccines. The position will preferably be based in Leiden, The Netherlands but may alternatively be based in Beerse, Belgium.
Janssen Research & Development develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
- The Associate Director, Global Regulatory Affairs – CMC will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to support the regulatory activities related to vaccines in all global markets. The Associate Director will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidances related to vaccines. Additional responsibilities include: contribute to the preparation and editing of clinical trial and marketing applications that include vaccines; correspondence and direct interaction with Health Authorities; leadership on external influencing and commenting on guidance and new regulations; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; and other related duties as assigned.
- The Associate Director ensures the development strategy meets global regulatory requirements over the lifecycle of the product. The Associate Director ensures that the CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP). The Associate Director ensures communication and alignment of the CMC regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader), project Compound Development Teams, and all other internal and external stakeholders, and appropriately escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product.
- BS degree in biological, pharmaceutical, or chemical sciences with generally a minimum of 10+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience, MS, Ph.D., or Pharm.D. degree preferred.
- At least 5 years of experience in CMC-Regulatory Affairs is required.
- Knowledge of vaccines required.
- Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred.
- Strong knowledge of EU and FDA regulations is required.
- Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
- Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
- Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and as an individual contributor, decision maker, and leader.
Janssen Biologics (7266)