Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Manager, Global Regulatory Affairs - CMC. The position can be located in US (Malvern/Chesterbrook, PA; Spring House, PA; Raritan, NJ; Titusville, NJ; La Jolla, CA; or Fremont, CA) and Europe (High Wycombe, UK; Leiden, Netherlands; Cork, Ireland; or Beerse, Belgium) and Canada (Toronto).
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 www.janssenpharmaceuticalsinc.com
The Manager, 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 and gene therapy in clinical development and post marketing in all global markets. The Manager will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to Large Molecules and Gene Therapy.
In this role, you will:
Participate as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally
Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.
Develop and execute global CMC regulatory strategy for one or more drug and/or delivery device, vaccine cell/gene therapy product(s).
Lead the preparation of regulatory dossiers for submission to Health Authorities.
Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed
May participate in selected initiatives within CMC RA / GRA
Participate in and conducts due diligence/licensing evaluations as needed
Drive a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management
Ensure the CMC development and commercial product regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the strategies of global regulatory affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP)
Assure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).
Refine regulatory strategies as new data become available.
Escalate issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product.
Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.
Effectively and tactfully communicates with health authorities; maintain good rapport and credibility.
Review CMC regulatory dossiers for global submissions throughout the product lifecycle
Provide accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.
A minimum of a Bachelor of Science in biological, pharmaceutical, chemical or engineering sciences with a minimum of 8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required. An MS, Ph.D., or Pharm. D. degree preferred.
Experience in biologics is required.
Experience in gene therapies is preferred.
Knowledge of EU and FDA regulations is preferred.
Experience directly writing submission documents that support clinical trials, marketing, and lifecycle management is preferred.
Experience in regulations or product development in gene therapy (ie. CAR-Ts, AAVs, CRISPR technology etc.) is preferred.
Demonstrated ability to communicate regulatory requirements is required.
Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.
Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is preferred.
Strong attention to detail with high-level verbal and written communication skills is required.
Communicates cross-functionally and cross-company is required.
Ability to present and defend CMC management-approved regulatory strategy and opinion to project teams is preferred.
Demonstrates model behavior that understands what the priorities are and encourages others to drive for results is preferred.
Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff is preferred.
Good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products is preferred.
Some understanding of competitors in the area and what they are doing in early/late development is preferred.
The position can be located in US (Malvern/Chesterbrook, PA; Spring House, PA; Raritan, NJ; Titusville, NJ; La Jolla, CA; or Freemont, CA) and Europe (High Wycombe, UK; Leiden, Netherlands; Cork, Ireland; or Beerse, Belgium) and Canada (Toronto) and 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.
North America-Canada-Ontario-Toronto, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-California-Fremont, 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, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)