Director Global Regulatory Affairs
Spring House, PA, USA | Johnson & Johnson
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Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, North American/Global Regulatory Leader.
The position will preferably be based in Spring House, PA, but flexible arrangements for other site locations can be negotiated.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Thriving in 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 Director, North American/Global Regulatory Leader, Immunology will be responsible for the development, implementation and maintenance of North American regulatory strategies for both large and small molecules with indications targeted in areas of Rheumatology, Gastroenterology, and Dermatology. In addition, the director will also be responsible for global regulatory strategies for select large and small molecule projects spanning the same target disease areas.
As Director, North American/Global Regulatory Leader (NA/GRL), Immunology, you will:
Be responsible for the development, implementation and maintenance of robust North American/Global regulatory strategies for both large and small molecules with indications targeted in areas of Rheumatology, Gastroenterology, and Dermatology.
Be a key contributor/leader on the Global Regulatory Team and on multiple cross-functional teams including but not limited to the Global Dossier Team, Clinical Working Group, the Labeling Working Group, and the Compound Development Team.
Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications. Scope of contribution (e.g., regional or global) will be dependent on role on program.
Assure that regulatory strategies throughout life cycle of compounds are in alignment with Immunology portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).
In interacting with the Health Authorities, the NA/GRL will lead and/or participate in meetings with FDA, Health Canada and other Health Authorities (HAs) as appropriate.
Preparing company personnel and developing contingency strategies for interactions with HAs.
Interacting with operating companies and development partners.
In NARL role, establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs as well as addendums & supplements.
In NARL role, lead the regulatory response team for FDA and Health Canada questions.
In GRL role, provide integrated global labeling and filing strategy for assigned projects.
In NARL role, manage routine maintenance submissions, manage & track NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities.
As the GRL, serve as a member of LWG to create or update the CCDS and contributes to the development of local labels as appropriate. In the NARL role, contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.
Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
A minimum of Bachelor’s degree is required and an advanced degree (MS, PhD, MD or Pharm D) is strongly preferred.
10 + years of pharmaceutical industry or health authority experience is required.
A minimum of 6 years of RA or related experience is required.
Experience leading interactions with Health Authorities is required.
Global regulatory experience is strongly preferred.
A broad understanding and experience in drug development including early and late development is required.
A broad understanding of lifecycle management is required.
Ability to interpret and understand regulatory requirements/precedent in the context of the scientific and commercial environment is required.
Previous experience in the Immunology therapeutic area is highly preferred
Deep knowledge of FDA and Health Canada regulations and guidelines related to the product/project life cycle is required.
Working knowledge of US labelling requirements is required.
Knowledge of FDA structures & how that Agency operates; knowledge & understanding of commercial business needs; and understanding of scientific data (clinical & non-clinical) is required.
Ability to work successfully in a matrixed environment as a leader and individual contributor
Project management skills, strong oral & written communication skills and organization & multi-tasking skills are required.
The position will preferably be based in Spring House, PA, but flexible arrangements for other site locations can be negotiated. Will be required to travel up to 10% domestic and internationally.
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