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J&J Family of Companies Global CMC Regulatory Affairs Manager in United States

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for Manager, Global Regulatory Affairs – Chemistry, Manufacturing, and Control (CMC). The position will focus on pharmaceutical drugs (i.e., small molecule products) and will be based at one of the following sites: preferred locations are any of the following Janssen sites. Raritan, NJ or Titusville NJ and other acceptable locations including Spring House, PA, and Europe (i.e., Beerse, Belgium, Allschwil , Switzerland, Cork, Ireland, Leiden, NL etc.). 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. Janssen’s 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.

Manager of Global Regulatory Affairs CMC is responsible for developing global CMC regulatory strategies and dossier content plans according to scientific/risk-based principles in consultation with their supervisor. The primary responsibility is to lead the CMC regulatory activities related to drugs (small molecules) in clinical development and post marketing in all global markets. Manager will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and strategical guidance related to pharmaceutical drugs (i.e., small molecules).

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.

  • Lead the preparation of regulatory dossiers for submission to Health Authorities.

  • Develop and execute global CMC regulatory strategy for one or more pharmaceutical drugs (i.e., small molecules) and/or delivery device.

  • Active participation in CMC Regulatory Systems and Processes

  • Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.

  • Develop and gain agreement with project teams on the regulatory CMC strategy for Health Authority responses/interactions as needed.

  • May lead/participate in selected initiatives within CMC RA / Global Regulatory Affairs (GRA).

  • 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.

  • 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

  • A BS/BA in pharmaceutical, chemical, biological or engineering sciences is required with a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree is preferred.

  • Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.

  • Experience in pharmaceutical drugs (i.e., small molecules) is required.

  • Experience developing regulatory strategies and an understanding of product development is preferred.

  • Experience in systems and processes

  • Knowledge of EU and FDA regulations is preferred.

  • Demonstration of model behavior that understands priorities and encourages others to drive for results.

  • High-level verbal and written communication skills. Strong attention to detail.

  • 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---

Other Locations

Europe/Middle East/Africa, United States-New Jersey-Titusville

Organization

Janssen Research & Development, LLC (6084)

Job Function

Regulatory Affairs

Requisition ID

2105986919W

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