Associate Director, CMC Regulatory Affairs
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an Associate Director, Regulatory Affairs - CMC to be based in Spring House, PA, Titusville, NJ, Raritan, NJ or Toronto, Canada.
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.
The Associate Director, Regulatory Affairs - CMC will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies. The primary responsibility is to support post-approval activities for a portfolio of small molecules.
• Responsible for developing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans.
• Lead the CMC regulatory activities for designated programs for small molecules products (API and drug product).
• Support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidances.
• Additional responsibilities may include: contribute to the preparation and editing of clinical trial and marketing applications; correspondence and direct interaction with global 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.
• Ensures the development strategy meets global regulatory requirements over the lifecycle of the product.
• 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).
• 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.
• A Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field with a minimum of 10 years of relevant industry experience OR a Master’s degree with a minimum of 8 years of relevant industry experience OR a PhD with a minimum of 5 years of relevant industry experience is required.
• A minimum of 3 years of experience in Regulatory Affairs-CMC is required.
• Direct regulatory experience with CMC documentation preparation for INDs, NDAs, IMPDs, MAAs and global dossiers is preferred.
• Strong knowledge of EU, FDA and global regulations is required.
• Experience in leading Health Authority meetings (FDA, EMA, Health Canada and others) is highly preferred.
• Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
• Proficiency with the MS Office suite of products and data management tools is required.
• Strong interpersonal, communication, teamwork, leadership, conflict management and negotiation skills is required.
• This position will be based in Spring House, PA, Titusville, NJ, Raritan, NJ or Toronto, Canada and requires up to 5% travel, both international and domestic.
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J2W: LI NA
United States-Pennsylvania-Spring House
North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, North America-Canada-Ontario-Toronto
Janssen Research & Development, LLC. (6084)