The Senior Director, 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, within targeted areas of primarily Rheumatology, Gastroenterology, and Dermatology including rare and ultrarare diseases.
As a global regulatory leader, this individual will be responsible for leading 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 (LWG), and the Compound Development Team.
Responsibilities will include: -
- serving as a member of LWG to create or update the CCDS and contributes to the development of local labels as appropriate and providing regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
- 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.
- 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.
- Provide regulatory strategic input into development of innovative drug development tools, study designs, endpoints, and drug/device combinations.
- In interacting with the Health Authorities, the GRL will lead strategy and participate in meetings with FDA, EMA, and other Health Authorities (HAs) as appropriate. This will also include preparing company personnel and developing contingency strategies for interactions with HAs.
- Contribute to due diligence efforts as requested
- As member of the Immunology GRA SLT, s/he will lead or contribute to key strategic initiatives for function, as appropriate (eg: talent development, external working groups, etc).
- Line manager for one or more direct reports within Immunology GRA.
- Contribute to strategic initiatives within the Immunology therapeutic area and / or Global GRA organisation as requested
- 10+ years of pharmaceutical industry/health authority experience is required; a minimum of 6 years of RA or related experience is required
- Advanced degree strongly preferred (MS, PhD, MD, or Pharm D)
- Global regulatory experience with deep knowledge of Global Health Authority regulations and guidelines related to the product/project life cycle, and experience leading interactions with Health Authorities is required.
- Previous experience in the Immunology therapeutic area or rare diseases
- 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 operate; 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
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-United States-New Jersey, North America-United States-New York, North America-United States-California, North America-United States, North America-United States-Massachusetts
Janssen Research & Development, LLC (6084)