Associate Director, Global Regulatory Affairs, CMC (Drug /Device Combination Products)
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate 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 any of the following J&J sites in the U.S., Chesterbrook, PA or Raritan, NJ and other acceptable locations include Spring House, PA, and Titusville, NJ, and OUS Beerse, BE, Leiden, NL, High Wycombe U.K. Other locations may be considered.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.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.
Develop global Chemistry, Manufacturing, and Control (CMC) regulatory strategies and dossier content plans related to drug-device combination product clinical trial and marketing applications for pre- and post-approval submissions in all global markets, including regulatory risk assessments and mitigations associated with proposed strategies
Ensure regulatory strategies are in alignment with the global regulatory strategy and refine regulatory strategies as new data become available.
Maintain up-to-date understanding of global combination product and medical device regulations and guidance documents and advise cross-functional project teams and CMC-RA on the interpretation and application of health authority expectations toward drug-device combination product submissions.
Provide regulatory assessments of the impact of CMC changes on combination product regulatory strategies and submissions.
Develop regulatory CMC strategy for Health Authority responses to combination product-specific questions as needed.
Participate in and conduct due diligence/licensing evaluations as needed.
Contribute to external influencing and commenting on guidance documents and new regulations.
Provide regulatory support to combination product development process activities and deliverables, including design control, risk management, and human factors.
Raise issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.
Actively collaborate with CMC RA project leads to build awareness of combination product regulatory expectations.
A Bachelor’s/undergraduate degree is required.
A Bachelor's degree and at least 8 years of regulated healthcare industry experience, or an advanced degree and a minimum of 6 years of regulated healthcare industry experience or a PhD with 4 years regulated healthcare industry experience.
A minimum of 2 years of experience developing or contributing to global regulatory strategies while working in a regulatory affairs or related function (i.e. R&D, quality, reg compliance) is required.
Experience working directly in regulatory affairs is preferred.
Experience developing drug-device combination products is preferred.
Knowledge of US medical device Quality System Regulations (Part 820) is required.
Knowledge of US combination product (21 CFR Part 3, 4) regulations is preferred.
Knowledge of device risk management principles (ISO 14971), and human factors and usability engineering principles is preferred.
Knowledge of global combination product and medical device regulations including current European Medical Device Directive and new EU MDR, ISO technical standards relevant to drug delivery devices (e.g. ISO 11608), and device complaint handling/medical device reporting is strongly preferred.
Experience with delivery device sections of Module 3 for pre- or post-approval submissions for drug-device combination products regulated as drugs is preferred.
Experience with any of the following medical device submissions is required: IDEs, 510(k)s, PMAs, technical files to support CE marking, or technical dossiers for Notified Body Opinions.
Experience in preparing for and/or participating in Health Authority meetings (FDA, EMA and other health authorities) is required.
Experience developing responses to device-related questions from Health Authorities is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan-920 US Highway 202 Other Locations
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Janssen Research & Development, LLC (6084) Job Function
Regulatory Affairs Requisition ID
Open Positions from Johnson & Johnson Family of Companies