J&J Family of Companies Director Global CMC Regulatory Affairs in Leiden, Netherlands
Janssen Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Global Regulatory Affairs – CMC with a focus on biotechnology derived products. The position will be based in Leiden, The Netherlands.
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.
We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
The Director, Global Regulatory Affairs – CMC is responsible for developing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to large molecules (mainly monoclonal antibodies) and vaccines in clinical development and post marketing in all global markets. The Director will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to biotechnology derived products. Additional responsibilities include: contribute to the preparation and editing of clinical trial and marketing applications that include biologics; correspondence and direct interaction with Health Authorities; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; external influencing and commenting on guidance and new regulations.
The Director ensures the development strategy meets global regulatory requirements over the lifecycle of the product. The 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 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, Supply Chain, 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. The Director provides management oversight of staff. The Director participates in and conducts due diligence/licensing evaluations and represents CMC Regulatory Affairs on global teams as well as Pharmaceutical Development and Supply Chain governance committees as needed.
Qualifications, Education, Skills and Experience:
A Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field with 12+ years of pharmaceutical industry experience is required. A Master’s degree with 10+ years of pharmaceutical industry experience or a PhD with 8+ years of pharmaceutical industry experience is highly preferred. At least 5 years of experience in Regulatory Affairs-CMC is preferred. Knowledge of large molecules required; knowledge of vaccines preferred.
Excellent people management skills
Fluent English (oral & written)
The strongest candidate will have direct and significant regulatory experience with biotechnology derived products and in CMC documentation preparation for INDs, BLAs, IMPDs, MAAs for large molecules. Strong knowledge of EU and FDA regulations is required. Experience in leading Health Authority meetings (FDA, EMA and national agencies) highly preferred. Knowledge of device regulations preferred. Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required. Strong interpersonal, teamwork, leadership, conflict management and negotiation skills are essential. Ability to manage and motivate people within a line and matrix team environment and as an individual contributor, decision maker, and leader required. This position requires up to 10% travel, both international and domestic.
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Janssen Biologics (7266)