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 can be located in US (Malvern/Chesterbrook, PA; Spring House, PA; Raritan, NJ; or Titusville, NJ) or Europe (Leiden, Netherlands; Cork, Ireland; or Beerse, Belgium).
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.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit http://www.janssenpharmaceuticalsinc.com
The Director, Global Regulatory Affairs – CMC is responsible for developing global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to large molecules in clinical development and post marketing in all global markets. The Director will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to Large and Small Molecules.
In this role, you will:
- Contribute to the preparation and editing of clinical trial and marketing applications that include biologics/small molecules.
- Correspond and have direct interaction with Health Authorities.
- Develop product-specific regulatory strategy documents.
- Complete the technical review and approval of master protocols, reports and other source documents.
- External influencing and commenting on guidance and new regulations.
- Develop strategy meets global regulatory requirements over the lifecycle of the product.
- 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).
- Communicate and align 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.
- Provide management oversight of staff.
- Participate in and conducts due diligence/licensing evaluations and represents CMC Regulatory Affairs on global teams as well as Pharmaceutical Development and Supply Chain governance committees as needed.
Qualifications
- 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.
- At least 5 years of experience in Regulatory Affairs-CMC is preferred.
- Knowledge of biologics required.
- Knowledge of small molecules is preferred.
- Excellent people management skills highly preferred.
- Direct and significant regulatory experience with biotechnology derived products and in CMC documentation preparation for INDs, BLAs, IMPDs, MAAs, and lifecycle management variations for large molecules preferred.
- Experience directly writing submission documents supporting clinical trial, marketing, and lifecycle management submissions is preferred.
- Strong knowledge of EU and FDA regulations is required.
- Experience in leading Health Authority meetings (FDA, EMA and national agencies) highly preferred.
- Knowledge of device regulations preferred.
- Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
- Strong interpersonal, teamwork, leadership, conflict management and negotiation skills required.
- Ability to manage and motivate people within a line and matrix team environment and as an individual contributor, decision maker, and leader required.
- This position can be located in US (Malvern/Chesterbrook, PA; Spring House, PA; Raritan, NJ; or Titusville, NJ) or Europe (Leiden, Netherlands; Cork, Ireland; or Beerse, Belgium) may require up to 10% travel, domestic and/or international.
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.
Primary Location
United States-Pennsylvania-Malvern-
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Chesterbrook, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
00001FPC
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