Director, Global Regulatory Leader (Oncology)

仕事内容

Janssen Research & Development, LLC., is recruiting for a Director Global Regulatory Leader (GRL) - Oncology. The position will focus on large and small molecules, as well as advanced therapy products, and is open to multiple locations throughout the US and EU. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC. is part of the Janssen Pharmaceutical Companies. 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. Key Responsibilities: Regulatory Strategy: Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussion with global health authorities to find the best development strategies for novel therapies Integrate multiple inputs from regional and functional GRT members to build and execute a coherent and unified global regulatory strategy for one or more product (s) Refine regulatory strategy as new data become available and re-assess, if vital Lead, facilitate, and coordinate GRT meetings Represent Regulatory viewpoint and expertise on the CDT, including regulatory risk/benefit evaluations associated with proposed strategies Provide direction on implications for regulatory strategy through participation in other teams (labeling working group, clinical, etc.) Accountable for regulatory recommendations for governance processes. Develop and update contingency plans for issues that affect study initiation, movement to full development, and registration scenarios. Confirm strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-RA strategy, commercial strategy, and Target Label HA Interactions: In collaboration with Regional and/or local Regulatory Leader, as applicable: Determine timing and strategy for HA meetings Prepare company staff for interactions When appropriate lead meetings with Health Authorities (HA) Develop strategy for providing responses to HA questions (ensure alignment with global strategy) Understanding of procedures for working with HA’s. Understanding procedures for approaching, influencing HA’s. Knowledge of HA’s historical stance on specific issues Submissions: Provide input to and be accountable for the preparation of dossiers for submission to HA (IND/CTAs/NDA / MAA) Work with the clinical and CMC teams to develop clinical trial submission plans Modify submission plan and align with sourcing, IP and if appropriate launch strategies Establish Rapid Response Team to develop and get consensus on global strategy for HA responses as needed Work with GRT and CDT to follow local regulatory requirements and commitments Knowledge of HA procedures that need to be followed. Understanding how a HA perceives, handles and provides feedback to submissions. Understanding of individual HA review practices. Regulatory Input into Other Functions: Conduct licensing evaluations (as needed) Work with the GRT to provide input for Target Label Co-lead the Labeling Working Group in making strategic decisions, including creation of Labeling strategy As a member of the clinical team, provide input on study design, conduct, country selection, and monitoring and identify need for any additional studies Provide feedback to Discovery and other functions that may translate into potential new compounds and uses Provide input to commercial Drug Product formulation, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy Provide input into risk/benefit assessment Work with GRT to advise, manage and resolve any “issues” as required with dedicated resources Coordinate with Regulatory Legal and Healthcare Compliance to address pertinent issues As part of CDT, review pertinent product/project-related communications, manuscripts, and publications Qualifications Education: Minimum of Bachelor’s/undergraduate or equivalent degree in a scientific or technical field (required) Advanced degree (MS, PhD, MD or Pharm D) (preferred) Experience and Skills: Required: 10+ years of pharmaceutical/biotech industry or health authority experience A minimum of at least 6 years of RA or related experience Minimum 4 years of experience within a supervisory capacity or leading teams within matrix environment Proven understanding of global HA laws, regulations, guidance, and global regulation submission routes available for new study drugs Understand the importance of competitive landscape into regulatory strategy Experience developing regulatory strategies and an understanding of product development Preferred: Experience developing sophisticated therapies (gene and cell therapies) Experience leading interactions with Health Authorities Diverse therapeutic area experience General knowledge of labeling aspects of competitors therapeutics Solid understanding of biology and chemistry relevant to the Oncology therapeutic area Other: The willingness and ability to travel up to 20% both international and domestic is required. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. 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. Primary Location United States-New Jersey-Raritan-920 US Highway 202 Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Somerville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse Organization Janssen Research & Development, LLC (6084) Job Function Regulatory Affairs Requisition ID 2206022927W