3 months ago
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Global Regulatory Leader - Oncology, located in our High Wycombe office (UK).
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Global Regulatory Leader for Oncology Projects integrates multiple inputs from regional and functional Global Regulatory Team (GRT) members to create coherent and unified global regulatory strategies. Key activities and responsibilities Include facilitating and coordinating of GRTs, representing Global Regulatory Affairs and providing regulatory expertise to the Compound Development Team (CDT) and Clinical Team (CT), facilitating successful product development globally and providing input on governance recommendations.
• Ensure regulatory strategies are updated throughout lifecycle of compounds as appropriate.
• Refine regulatory strategies as new data become available and re-assess as necessary.
• Develop and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensure strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile.
• Lead the preparation of regulatory dossiers for submission to Health Authorities (HAs).
• Lead GRT(s) to develop global marketing approval submission plans and timing, modify these plans when necessary, and align with sourcing, Intellectual property and launch strategies as appropriate.
• Establish Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to HAs.
• Work with the GRT to deliver input for target labelling, and the Labelling Working Group in making strategic decisions, including the creation of Labelling strategy.
• Participate in and conduct licensing evaluations as needed.
The role will require business related travel between 10-20% of the time.
- 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: Your able to persuade, convince, or influence others, to gain commitment with an idea or a course of action he or she wants others to adopt.
- 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 faced with conflict from others, or when working under conditions of stress; puts interest of enterprise above own; keeps the focus of driving customer value and delivering results under stressful situations; 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; has committed dissatisfaction with status quo; motivated to leave things better than they were; a change agent. Able to identify patterns or connections between situations that are not obviously related, and to identify key or underlying issues in complex situations; includes using creative, conceptual or inductive reasoning.
Do you have the following background, experience and Knowledge?
- Minimum of Bachelor’s degree in a scientific discipline required
- Advanced degree (MS, PhD, MD or Pharm D) strongly preferred
- 10+ years of pharmaceutical industry or health authority experience and at least 6 years of RA or related experience
- Minimum 4 years of experience within a supervisory capacity or managing teams within matrix environment
- Wide range of experience in Global Regulatory Affairs and experience leading interactions with Health Authorities
- Working knowledge of WW HA laws, regulations, guidance and global regulation submission routes available for new study drugs
- Detailed understanding of competitors in the area and what they are doing in early/late development and knowledge of labelling aspects
- Deep understanding of biology and chemistry relevant to the Oncology therapeutic area requirements
- Experience developing regulatory strategies and an understanding of product development
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)