- Bring innovative regulatory approaches, deeply rooted in science to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist
- Integrate multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified regional regulatory strategies
- Be responsible for the development, implementation and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development
- Drive the execution of the regulatory strategies for select projects through close collaboration with functional areas
- Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with NA regional teams’, CMC, commercial strategies, and the Target Product Profile
- Ensure that regulatory strategies also take into account non-regulatory market access issues (e.g., health technology assessments, payor demands)
- Lead the preparation of regulatory dossiers for submission to FDA and Health Canada.
- Lead the preparation and participate in meetings with FDA, Health Canada and other Health Authorities (HAs)
- Serve as a member of the Labelling Working Group 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
- Ensure compliance with internal and external policies and legislation
- Support or lead Due Diligence activities as appropriate
- Results and Performance Driven/Initiative: You will be assuming personal ownership and accountability for business results and solutions; you can easily identify a problem, obstacle or opportunity and act to address current or future problems or opportunities.
- Organization and Talent Development: You have a Proven ability to foster the long-term learning or development of others.
- Impact and Influence: You are able to persuade, convince, or influence others, to gain commitment with an idea or a course of action.
- Organization Awareness: You understand the power relationships in one’s own organization and in other organizations.
- Self-Awareness and Flexibility: You are able to keep one’s emotions under control and act expertly when working under conditions of stress; puts interest of enterprise above own; the ability to adapt to, and work effectively within a variety of situations, and with various individuals or groups.
- Strategic and Conceptual Thinking: You are driven to envision a better future; takes any role or job and makes it better. Able to identify key or underlying issues in complex situations;
- Minimum of Bachelors degree in a scientific discipline required;
- Advanced degree (MS, PhD, MD or Pharm D) strongly preferred;
- Minimum of 10 years’ experience in either pharmaceutical industry, medical device industry, consumer industry or health authority regulated industry is required
- At least 6 years of Regulatory Affairs experience required with focus on the NA region and FDA;
- Experience in pulmonary hypertension is preferred;
- Minimum of 4 years’ experience within a supervisory capacity or managing teams within matrix environment required;
- Experience establishing productive working relationships with FDA/CDER and gaining a deep understanding of how the FDA views certain drug development issues
- Working knowledge of WW HA laws (with a focus on FDA), regulations, guidance and regulation submission routes available for new study drugs is required;
- Ability to maintain knowledge of competitors in the therapeutic area and what they are doing in early/late development and knowledge of labeling aspects required;
United States-New Jersey-Cherry Hill-
United States, United States-New Jersey, United States-Pennsylvania
Janssen Research & Development, LLC (6084)