Associate Director, Regulatory Affairs
Associate Director, Regulatory Affairs - Chemistry, Manufacturing, and Control (m/f/x, 100%)
Janssen Research & Development, a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director, Regulatory Affairs - Chemistry, Manufacturing, and Control (CMC). The position will focus on vaccines and will be based at one of the following Janssen sites in Europe: Leiden, Netherlands; Bern, Switzerland; or Beerse, Belgium. US locations may be considered.
Janssen Research & Development 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.
The Associate Director, 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 vaccines in clinical development in all global markets. Experience with vaccines is required. The Associate Director will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and guidance related to Vaccines.
In this role, you will:
- Participate as the Regulatory CMC Lead on CMC Teams and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development and commercialization globally.
- Actively participate on Global Regulatory Team(s) to develop global submission plans that follow local regulatory requirements and commitments.
- Develop and execute global CMC regulatory strategy for vaccines.
- 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.
- 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).
- Raise 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.
- A BS/BA in biological, pharmaceutical, chemical or engineering sciences is required. An MS, Ph.D., or Pharm. D. degree an asset.
- A minimum of 10+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required.
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.
- A minimum of 5 years of experience developing or contributing to global regulatory strategies while working in a CMC regulatory affairs or related function (i.e. R&D, quality, reg compliance) is required.
- Experience in biologics and product development of vaccines is required.
- Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred. Additional post-approval experience is a plus.
- Knowledge of EU and FDA regulations is required.
- Experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff 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.
Netherlands-South Holland-Leiden- Other Locations
United Kingdom-England-High Wycombe, Switzerland-Berne-Bern, Switzerland-Zug-Zug, Belgium-Antwerp-Beerse
Janssen Biologics (7266)