Johnson & Johnson Careers
Director, Global Regulatory Affairs, CMC
Raritan, New Jersey; Titusville, New Jersey; Malvern, Pennsylvania; Spring House, Pennsylvania
Requisition ID: 7651190614
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Global Regulatory Affairs, CMC . The position will focus on drug-device combination products and will be based at one of the following sites: preferred locations are Malvern, PA or Raritan, NJ and other acceptable locations include Spring House PA and Titusville NJ.
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, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
The Director, Regulatory Affairs, CMC will:
• Lead a group of 5 regulatory scientists that 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 submissions in all global markets.
• You will play a key role in supporting the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans for combination products throughout the lifecycle of the product
• Contribute to the preparation and editing of clinical trial and marketing applications that include delivery devices.
• 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
• You will build positive relationships, prepare correspondence and lead interactions with Health Authorities regarding Combination Products
• Provide technical review and approval of test protocols, reports and other source documents.
• Contribute to external influencing and commenting on guidances and new regulations.
• Ensure 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).
• Ensure 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.
• Participate in and conduct due diligence/licensing evaluations and represent CMC Regulatory Affairs on global teams as well as Pharmaceutical Development and Supply Chain governance committees as needed.
• A Bachelor’s degree with 10+ years of pharmaceutical or medical device industry experience OR a Master’s degree with 8+ years of pharmaceutical or medical device industry experience OR a PhD with 6+ years of pharmaceutical or medical device industry experience is required.
• A degree in Pharmacy, Chemistry, Biology or a related science/technical field is preferred.
• At minimum of 5 years of experience in Regulatory Affairs is required
• Previous experience developing CMC regulatory strategy for pre and post-approval combination products is required
• Previous experience with combination products is required.
• Direct experience in the preparation of delivery device sections (Module 3) in any one of the following submissions NDA/BLA/MAA is required
• Previous experience with medical device submissions PMAs, 510(k)s, IDEs, MAFs, CE Mark Technical Files is preferred..
• 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.
• Experience in leading Health Authority meetings (FDA, EMA and national agencies) is required.
• Previous experience managing directly/indirectly other people to manage in a matrix team environment is required.
• The ability to be located at one of the following locations: preferred Malvern, PA; or Raritan, NJ BUT other acceptable locations include Spring House PA and Titusville NJ is required as well as the ability to travel up to 10%.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
United States-New Jersey-Raritan-
United States-New Jersey-Titusville, United States-Pennsylvania-Malvern, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)