Associate Director, Global Regulatory Affairs, CMC

10 Jul, 2022

Jobs

Associate Director, Global Regulatory Affairs, CMC

Johnson & Johnson
Raritan, NJ; Spring House, PA; Chesterbrook, PA; Titusville, NJ

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, CMC. Preferred locations are Chesterbrook, PA or Raritan, NJ and other acceptable locations include Spring House, PA, and Titusville, NJ. Other locations throughout the U.S. and Europe may be considered on a remote basis. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.

This role in Global Regulatory Affairs CMC is responsible for developing global CMC regulatory strategies and content plans. The primary responsibility is to lead CMC regulatory activities related to large molecule/cell and gene therapy programs in clinical development and post marketing in all global markets. The individual will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and strategical guidance.

Position expectations:

  • Participate as the Regulatory CMC Lead on teams and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
  • Actively participate on teams 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, large molecule, cell and gene therapy products.
  • 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.
  • 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 program.
  • Assure connectivity to the overall global regulatory strategy through partnership and communication with the overall 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; build positive relationships and maintain good rapport and credibility.
  • Review CMC regulatory dossiers for global submissions throughout the product lifecycle.
  • Provide accurate regulatory assessments of CMC changes to teams/projects and execute regulatory planning and implementation.

Qualifications

  • A minimum of BS/BA in biological, pharmaceutical, chemical or engineering sciences with at least 9 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 is preferred.
  • Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.
  • A minimum of 2 years of experience developing or contributing to global regulatory strategies in a related function (i.e. R&D, quality, reg compliance) is required.
  • Experience in biologics, product development/lifecycle management is required.
  • Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is preferred.
  • Knowledge of EU and FDA regulations is required.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

The base pay range for this position is $129k to midpoint $194K.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

Information on benefits can be viewed by following this link: https://www.careers.jnj.com/employee-benefits

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.

Learn more here

Job posted: 2022-07-10