SENIOR DIRECTOR GRA IMMUNOLOGY
- United States
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 on a 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 Senior Director, North American/Global Regulatory Leader, Immunology will be responsible for the development, implementation and maintenance of Global regulatory strategies for both large and small molecules with indications targeted in areas of primarily Rheumatology, Gastroenterology, and Dermatology. As a global regulatory leader, this individual will be responsible for leading complex Global regulatory teams and overseeing the activities of global regulatory professionals within this team and may be asked to serve as a direct line manager.
The Senior Director, Global Regulatory Leader (GRL), Immunology will:
- Be responsible for the development, implementation and maintenance of robust Global regulatory strategies for both large and small molecules with indications targeted in areas of primarily Rheumatology, Gastroenterology, and Dermatology.
- Lead 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.
- 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 GRL will lead strategy and 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 GRL role, provide integrated global labeling and global dossier submission strategy for assigned projects, working closely with NARLs, EURLs, and other regional leads in ensuring all local content requirements are met and HA questions are addressed.
- 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.
- Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
- As member of the Immunology GRA SLT, contribute to key strategic initiatives in leadership or supportive role, as appropriate (eg: talent development, communications, strategic initiatives, etc).
Qualifications & Main requirements :
• A minimum of Bachelor's degree is required.
• 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.
• 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.
• Working knowledge of US and EU labelling requirements is required.
• Knowledge of Global Health Authority structures & how Agencies 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 (matrixed and or direct people manager) and individual contributor
• Project management skills, strong oral & written communication skills and organization & multi-tasking skills are required.
Preferred Requirements :
• A degree in a scientific discipline is strongly preferred.
• An advanced degree (MS, PhD, MD or Pharm D) is strongly preferred.
• Global regulatory experience is strongly preferred.
• Previous experience in the Immunology therapeutic area or rare diseases is preferred.
• Deep knowledge of Global Health Authority regulations and guidelines related to the product/project life cycle is preferred.
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.
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.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)
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