GLOBAL REGULATORY TEAM LEAD/US REGIONAL REG. LEAD ONCOLOGY
Industry: Pharmaceutical / Biotech
Job Category: Research & Development
Global Regulatory Team Lead (GRTL) is responsible for developing the global regulatory strategy for the assigned projects. The GRTL has regulatory accountability globally for each program, working with the Global Regulatory sub-team (regions, Regulatory CMC, Regulatory Operations, labeling) to develop and execute robust regulatory strategies.
1.Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team and is the single point of contact for the business and R&D from regulatory. The GRTL provides regulatory advice and strategy for projects and ensures timely execution of regulatory activities.
2.Manages the Global Regulatory project sub-teams and ensures effective communication between cross functional project teams and the regulatory sub-teams; oversees planning and execution of global regulatory activities and submissions.
3.Collaborate to develop 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 sub-team to ensure relevant input from all GRA functions is vetted and included in the regulatory strategy.
4.Create regulatory strategy information for presentation during leadership governance meetings. The GRTL ensures GRA Sr. Management alignment with strategy, risks and mitigation and for presenting a unified regulatory voice.
5.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.
6.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.
1.Is the US regulatory appointment to senior management governance committees as needed.
2.Creation of plans, content, timing, execution of all US FDA submissions.
3.Works with global Regulatory CMC and Labeling sub-team representatives to ensure comprehensive support for US submission activities.
4.Continuously updates professional expert knowledge of evolving US regulations, FDA initiatives, ODAC outcomes and concerns.
1.7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally).
2.Regulatory lead experience in US or EU.
3.BS in a scientific discipline.
1.Advanced degree preferred.
2.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
2.Knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
3.Direct interaction or negotiation with regulatory authorities such as FDA, EMA.
4.Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
5.Excellent operational skills including planning, organizing and ability to motivate and lead others.
6.Ability to collaborate within cross-functional teams.
7.Excellent oral communication and writing skills
8.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.