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The oncology Global Regulatory Team Lead (GRTL) and US regulatory lead is a dual role within the organization based in the US. He/she is responsible for developing long and short-term regulatory strategies that impact the company's business plan and ensure achievement of global and US regulatory/business objectives.
Specific responsibilities include:
Global Regulatory Team Lead (GRTL) is responsible for developing the global regulatory strategy for the project or projects in his/her remit. In this capacity, the GRTL has regulatory accountability globally for the program, working with the Global Regulatory sub team (regions, Regulatory CMC, Regulatory Operations, labeling) to develop and execute robust regulatory strategies.
•Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team. In this capacity, the GRTL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL provides regulatory advice and strategy for the project(s) and ensures timely execution of regulatory activities.
•Manages the Global Regulatory project subteam(s). Ensures effective communication between cross functional project team and regulatory subteam; oversees planning and execution of global regulatory activities and submissions.
•Ensure development of robust global regulatory strategies for the program and is accountable for developing and maintaining a regulatory strategy document. The regulatory strategy addresses the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory subteam to ensure relevant input from all GRA functions is vetted and included in the regulatory strategy.
•Responsible for developing regulatory strategy information for presentation during leadership governance meetings. The GRTL is accountable for ensuring GRA Sr. Management alignment with strategy, risks and mitigation and for presenting a unified regulatory voice.
•The GRTL is responsible for ensuring communications from HAs are disseminated in a timely manner and properly interpreted, to the project teams, the business unit, and GRA Sr. Management.
•Provide regulatory due diligence assessments of new business opportunities as required.
The US Regional Regulatory Lead is the project liaison with FDA and responsible for development and execution of the US regulatory strategy.
• Represents the US regulatory position to senior management governance committees as needed.
•Responsible for development of plans, content, timing, execution of all US FDA submissions.
•Collaborates with global Regulatory CMC and Labeling subteam representatives to ensure comprehensive support for US submission activities.
•Maintains expert knowledge of evolving US regulations, FDA initiatives, ODAC outcomes and concerns.
7+ to 10 years experience
Management Experience Required - No
Minimum Education - Master's Degree
Willingness to Travel - Occasionally
7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Regulatory lead experience in US or EU. BS in a scientific discipline.
Advanced degree preferred.
Experience with least one major marketing application (NDA/BLA/MAA/JNDA etc...), or extensive experience with late stage development/marketed products.
Knowledge, Skills and Other Experience
•Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
• Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
• Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
• Excellent operational skills including planning, organizing and ability to motivate and lead others.
•Ability to work well within cross-functional teams
•Can demonstrate solid oral communication and writing skills
•Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
•Develops collaborative relationships to facilitate the accomplishment of work goals
•Generates innovative solutions in work situations, trying different and Client ways to deal with work problems and opportunities
•Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
•Can build networks to obtain cooperation without relying on authority
•Strong sensitivity for a multicultural/multinational environment
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