Johnson & Johnson

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Originele vacaturetekst

Associate Director; CMC Regulatory Affairs - Cell & Gene Therapy

Job Description

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Global Regulatory Affairs – Chemistry, Manufacturing, and Control (CMC). The position will focus on cell and gene therapy products and will be based at one of the following sites: preferred locations are any of the following Janssen sites. Chesterbrook, PA or Raritan, NJ and other acceptable locations include Spring House, PA, Titusville, NJ and Europe (Leiden, Netherlands; Cork, Ireland; or Beerse, Belgium). Other locations throughout the U.S. may be considered.

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, vaccines, and reproductive medicine. Please visit http://www.JanssenRnD.com for more information.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

The Associate Director, Global Regulatory Affairs – CMC is responsible for developing global CMC regulatory strategies and content plans. The primary responsibility is to lead the CMC regulatory activities related to cell and gene therapy in clinical development and post marketing in all global markets. Experience with large molecules is also desired The Associate Director 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 as well as large molecule.

In this role, you will:
  • Participate as the Regulatory CMC Lead on CMC/Value Chain Teams and represent 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 and gene therapy product(s).
  • Lead the preparation of regulatory dossiers for submission to Health Authorities.
  • Develop and gain agreement with project teams on the regulatory CMC strategy for Health Authority responses as needed.
  • May lead selected initiatives within CMC RA / Global Regulatory Affairs (GRA).
  • Participate in and conducts due diligence/licensing evaluations as necessary.
  • May provide oversight of assigned staff.
  • Drive a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.
  • May represent CMC RA on Cross Functional Teams.
  • May serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise.
  • 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 GRA, 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).
  • Escalate issues to CMC RA 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 communicate with health authorities; build positive relationships and maintain good rapport and credibility. When appropriate, lead meetings with Health Authorities under supervision of a senior member of the department.
  • Review CMC regulatory dossiers for global submissions throughout the product lifecycle.
  • Provide accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation.
Qualifications
Qualifications
  • A Bachelor’s and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
  • A minimum of 10+ 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.
  • A minimum of 2 years of experience developing or contributing to global regulatory strategies while working in a regulatory affairs or related function (i.e. R&D, quality, reg compliance) is required.
  • Experience in biologics is required.
  • Knowledge of EU and FDA regulations is required.
  • Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is preferred.
  • Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is required.
  • Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.
  • Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff is preferred.
  • An understanding of health authority laws, regulations, guidance and regulation submission routes available for assigned products is preferred.
  • Good understanding of competitors in the area and what they are doing in early/late development is preferred.
  • The ability to potentially travel 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-200 Great Valley Parkway
Other Locations
North America-United States-North Carolina-Raleigh, North America-United States-Indiana-Indianapolis, North America-United States-Maryland-Baltimore, North America-United States-Georgia-Atlanta, North America-United States-Pennsylvania-Chesterbrook, Europe/Middle East/Africa-Ireland-Cork-Cork, United States-New Jersey-Raritan, United States-California-San Diego, United States-Florida-Jacksonville, United States-Florida-Miami, United States-Illinois-Chicago, United States-New York-New York, United States-Ohio-Cincinnati, United States-Pennsylvania-Spring House, United States-Texas-Houston, United States-Texas-San Angelo, Belgium-Antwerp-Beerse, Netherlands-South Holland-Leiden, United States-California-San Francisco, United States-Washington-Seattle, United States-North Carolina-Charlotte, United States-Pennsylvania-Philadelphia, United States-Massachusetts-Boston, United States-District of Columbia-Washington
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
2105899446W
Type vacature:
Intern

Vaardigheden

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