Johnson & Johnson Careers
Associate Director, Regulatory CMC Dossier Development (1 of 2)
Requisition ID: 9038180416
- Authors/drives sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations
Supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications with limited guidance from the manager.
Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager.
Ensures all Quality submissions are completed in a timely manner.
Manages functional or project teams with up to 15 members; Acts as a mentor to one or more individuals
- Bachelor’s degree in Chemistry or related science with at least 10 years of relevant industry experience OR a Master’s degree with at least 8 years of relevant industry experience OR PhD with at least 6 years of relevant experience (industry, post-doctoral, graduate course work, etc.) is required
- Large Molecule and/or small molecule CMC regulatory writing experience is required
- At least 3 years of direct CMC regulatory marketing application writing experience in a Regulatory Affairs, Dossier Development or Technical Support Function group is required
- Technical background in chemistry, pharmaceutics or related science is required
- Must possess scientific understanding of pharmaceutical development functions as well as knowledge of the proper interpretation of applicable global regulatory guidances
- Proficiency in commonly used computer applications including WORD, EXCEL etc. required
- This position requires local travel and up to 10% international travel. This position may be located in Springhouse, PA, Malvern, PA, Raritan, NJ or Titusville, NJ. If the candidate is located in Raritan, NJ, Titusville, or Malvern, PA additional travel to Springhouse, as needed by business may be required
United States-Pennsylvania-Spring House
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC. (6084)