Associate Director, NA Regulatory Affairs

10 Jul, 2022

Jobs

Associate Director, NA Regulatory Affairs

Johnson & Johnson
Remote

Job Description

Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for a Regulatory Affairs Associate Director North America to be based in Spring House, PA. Remote work options in the United States and Canada may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Regulatory Affairs Associate Director (North America) will be responsible for the development, implementation, and maintenance of US regulatory strategies with indications targeted in Immunology and collaborates with co-development partners on global regulatory strategies.

Regulatory Affairs Associate Director (North America) Liaison responsibilities include:

  • Responsible for developing, refining and implementing North American regulatory strategy.
  • Leads and facilitates cross team activities related to regional strategy, including providing input on implications of regulatory strategy through participation in product-related teams (eg, Clinical and Labeling working groups, Dossier Submission Teams, Global Regulatory Team (GRT)).
  • Within the context of the global strategy, determines timings, appropriate NA regional strategy and content for all HA meetings.
  • Develops and updates contingency plans for regulatory strategies.
  • Determines timing, appropriate NA regional strategy and content for all HA meetings within the context of the global strategy.
  • Serves as primary contact with North American Health Authorities (HA) &/or Operating Companies. Works daily with regulatory agencies and leads/participates in other meetings with NA regulatory agencies.
  • Prepares company personnel for interactions with HA.
  • Works with the GRT to develop global marketing approval submission plan and timing.
  • Defines, generates, and submits appropriate data-driven responses to NA regional HA questions. Ensures that responses to FDA questions are handled in a timely manner and in line with the approved product strategy. Provides input to and reviews submission documents to ensure they accurately answer the questions being posed and are consistent with HA commitments.
  • Provides input to Submission Team to define submission plans including timing for new IND/CTA or IND/CTA amendments and HA reporting requirements; IND/CTA submission dossier content, scope, and timing. Contributes to preparations for Common Technical Document (CTD).
  • Manages lifecycle management submissions (including safety reports).
  • Negotiates and manages NA regional post-approval commitments.
  • Manages Adverse Experience (AE) safety reporting.
  • Reviews labeling to ensure adequate documentation supports the regional labeling text.
  • Approves submissions before dispatching to regulatory authorities.

Additional Responsibilities:

  • Serves as member of the Labeling Working Group (LWG) to derive and update proposed CCDS/USPI based on target labels. Participates in building the labeling negotiation strategies and development of supporting documentation for labeling. Negotiates regional labeling with Health Authorities, going through each of the back-up strategies if necessary.
  • Supplies input on study design, conduct, and need for any additional studies.
  • Provides input into risk/benefit assessment.
  • Creates strong interpersonal relationships partnering with cross-functional team members and positively deliver on people management and resource planning responsibilities.
  • Builds positive relationships and interacts with local NA commercial operating companies on individual products / processes.

Qualifications

  • Minimum Bachelor’s degree and at least 11 years of health regulated industry experience, or an advanced degree and a minimum of 9 years of health regulated industry experience.
  • At least 5 years (required) Regulatory Affairs (8 years of Regulatory Affairs experience is highly preferred).
  • A good understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
  • Knowledge of HA organizational structure and HA processes for reviewing submissions is required
  • Good understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
  • The ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required
  • The ability to effectively prioritize assignments for multiple products and projects simultaneously is required

Other:

  • Fluency in English required.
  • Travel Percentage: 10% domestic travel and potential international travel will be required for this position.

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.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Learn more here

Job posted: 2022-07-10