Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs, CMC with a focus on delivery devices and combination products. The position will be based in Malvern, PA, Spring House, PA, Titusville, NJ, Raritan, NJ, or Fremont, CA.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Infectious Disease and Vaccines, Metabolic, Neuroscience and Immunology. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Associate Director, Regulatory Affairs, CMC will:
• Contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans.
• Support the regulatory activities related to Drug-Device Combination Products and Drug Delivery Devices for the Company's product line, including pre- and post-approval and in all global markets.
• Support both Drug and Device Development Teams and provide direction on the interpretation and application of global CMC and delivery device regulations and guidances related to combination products.
• Prepare and edit marketing applications that include combination product technical performance, safety, quality and suitability information
• Correspondence and direct interaction with Health Authorities
• Leadership on external influencing and commenting on guidances and new regulations
• Training of staff on combination product regulatory requirements
• Development of product-specific regulatory strategy documents
• Technical review and approval of device design verification and validation protocols, reports and other source documents
• Provide regulatory input to human factors studies, delivery device clinical trials, risk analyses and patient Instructions for Use
• Ensures the development strategy meets global regulatory requirements over the lifecycle of the product.
• Ensures that the CMC/device regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP).
• Ensures communication and alignment of the delivery device regulatory strategy through partnership and communication with all Quality functions, 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.
• A Bachelor’s degree is required, preferably in Pharmacy, Chemistry, Biology or a related science/technical field.
• A Bachelor’s degree with 10+ years of pharmaceutical or medical industry experience OR a Master’s degree with 8+ years of pharmaceutical or medical device industry experience OR a PhD with 5+ years of pharmaceutical or medical device industry experience is required.
• An advanced degree in a technical or engineering discipline is strongly preferred.
• At least 5 years of experience in Regulatory Affairs, Quality, and/or R&D in the medical device or drug delivery device industry is required.
• Direct experience in the preparation of medical device PMAs, 510(k)s, IDEs, MAFs, CE Mark Technical Files, AND/OR NDA/BLA/MAA ICH eCDT Module 3 delivery device sections is required.
• Strong writing skills are absolutely essential.
• Significant knowledge of device regulations [i.e., 21 CFR Parts 3, 4 and 800, QSR (Design Controls), European Medical Device Directive, ISO technical standards (ISO 11608), CE Marking, device complaint handling/MDRs, human factors testing, and device risk analysis (ISO 14971] is strongly preferred.
• This position is located in Malvern, PA, Spring House, PA, Titusville, NJ, Raritan, NJ, or Fremont, CA, and may require up to 10% travel.
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J2W: LI NA
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Malvern, North America-United States-California-Fremont
Janssen Research & Development, LLC. (6084)
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