Website Johnson & Johnson
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular, metabolic, and retinal 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.
- Represent regulatory in Disease Area Stronghold (DAS) committed to advancing internal early development targets and expanding our portfolio through external innovation.
- Bring innovative regulatory approaches, deeply rooted in science to lead the discussion with global health authorities
- Collaborate with DAS and find the best development strategies for novel therapies in new areas of interest.
- Lead the regulatory review of Due Diligence activities as appropriate.
- Be responsible for integrating inputs from regional and functional Global Regulatory Team members to create coherent and unified regulatory strategies.
- Lead the Global Regulatory Team (GRT) and contribute optimally on multiple cross-functional teams including but not limited to the
- Compound Development Team (CDT), Disease Area Stronghold (DAS).
- Collaborate cross-functionally and ensure that regulatory strategies also take into account novel use of DataScience, non-regulatory market access considerations, etc.
- Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label.
- Ensure compliance with internal and external policies and legislation.
- Actively contribute and lead all aspects of the preparation of regulatory documents including but not limited to labelling, dossier contents, briefing books and other essential documents. Own the preparation of regulatory dossiers for submission to FDA and review global regulatory submissions.
- Minimum of a B.S. in a life sciences is required,
- An advanced degree (e.g., M.S., Ph.D) is desirable
- A minimum of 10 years in a Global Regulatory Affairs OR Drug Development OR R&D OR health authority role is required
- A Minimum 5 years of experience working in a regulatory affairs function inclusive of any experience working for a health authority is required
- A track record of innovative thinking and application is required
- Significant experience in the development and execution of global regulatory strategies, the drug development process, regulatory compliance, and regulatory strategy for product lifecycle management is required.
- Experience in conducting regulatory evaluations in support of due diligence activities would be highly beneficial.
- Experience working in rare disease or orphan disease indications would be very beneficial
- Experience working within the renal and hepatic is highly beneficial
- Demonstrable experience of establishing productive working relationships with FDA/CBER and gaining a deep understanding of how the FDA views certain drug development issues is required.
- Experience leading teams and coach individuals within their development is preferred.
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Philadelphia, PA, US
Application Deadline: N/A