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Director, Global CMC Regulatory Affairs
Requisition ID: 3805180219
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 preferably be based in Malvern, PA but may alternatively be based in Spring House, PA, Raritan, NJ, or Titusville NJ.
Janssen Research & Development, L.L.C. 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.
The Global CMC Regulatory Affairs Director is responsible for developing global CMC regulatory strategies and dossier plans according to scientific/risk-based regulatory strategies.
- Ensures the development strategy meets global regulatory requirements over the lifecycle of the product.
- Ensures CMC regulatory strategy is in alignment with global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Quality Target Product Profile (QTPP).
- Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).
- Participates as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
- Refines regulatory strategies as new data become available.
- Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance, and continued lifecycle management of the product.
- Reviews and approves regulatory dossiers for submission to Health Authorities.
- Actively participates on Global Regulatory Team(s) to develop global marketing approval submission plans.
- Provides accurate regulatory assessments of chemistry, manufacturing and controls changes to teams/projects and executes regulatory planning and implementation.
- Has expertise in at least two areas of Regulatory Affairs (e.g. small molecule and large molecule or pre-approval and post-approval).
- Participates in and conducts due diligence/licensing evaluations as needed.
- May manage a staff, including objective setting and career development activities.
- May represent CMC Regulatory Affairs Department on global teams as well as PDMS and JSC governance committees.
- A Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field with 12+ years of pharmaceutical industry experience OR a Master’s degree with 10+ years of pharmaceutical industry experience OR a PhD with 8+ years of pharmaceutical industry experience is required.
- Strong people management skills required.
- High-level verbal and written communication skills.
- Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to corporate project teams; recognizes global regulatory impact
- Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
- Experience leading interactions with Health Authorities.
- Strong knowledge of global HA laws, regulations, guidance, and global regulation submission routes available for new study drugs.
- Detailed understanding of competitors in the area and what they are doing in early/late development.
- Solid understanding of biology and chemistry relevant to pharmaceutical industry.
- Experience developing regulatory strategies and seen as an expert on product development and how it is applied.
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.
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)