Job Summary

• Primary representative for EU (EU, UK, CH, AUS, NZ) regulatory strategy for the designated early phase Oncology portfolio,  
• Oversee and contribute to the development of EU regional strategies for the designated early phase Oncology portfolio as a member of the Global Regulatory Strategic Team (GRST).
• Lead, oversee, and/or implement EU regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals
• Supervise EU regulatory strategists, and be accountable for staff and talent development, career development and planning and performance management.
• Accountable for timely submissions and approvals in the EU for the designated early phase Oncology portfolio
• Accountable for ensuring optimal regulatory interactions with EU Health Authorities for programs in the  designated early phase Oncology portfolio
• Contribute to the EU Oncology Regulatory Strategy Leadership Team and drive the required culture and behaviors through the organization
• Champion flexible approaches to ensure efficient and effective resource utilization
• Role can be combined with other Regulatory Role(s) (i.e. , Global Regulatory Lead)

Job responsibilities

• Is the senior global representative for EU regulatory strategy for the designated early phase Oncology portfolio including strategic and technical contributions
• Provides EU regulatory expertise and leadership within the designated early phase Oncology portfolio
• Ensure regional EU contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned products/projects
• Ensures EU regulatory contributions achieve the objectives against agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities
• Partners with project teams and other customer groups (e.g. Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, CTA, etc.) meet business needs and are provided to the project teams, to agreed time and quality standards
• Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated
• Ensures an aligned EU regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the EU business are championed and Engages/contributes in appropriate activities in order to influence the EU regulatory environment through GRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate
• Ensures business compliance and implementation of and adherence to Regulatory standards
• Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the EU region
• Contribute to aggregate resource forecasting for the projects/products within the assigned early phase Oncology portfolio
• Mentors, develops and coaches EU Regulatory Strategists/GRL(s) as applicable for projects within the designated early phase Oncology portfolio including aspects of performance management as appropriate
• Supports the EU Oncology Regulatory Strategy Leadership Team and drives the required culture and behaviors through the organization
• Champions flexible approaches to ensure efficient and effective resource utilization
• Ensures learning is embedded in the organization

Organizational relationship

• Reports to EU Regulatory Strategy Head
• Supervises EU regulatory strategists for the designated early phase Oncology portfolio
• Partners with GRLs/ Global head within early phase Oncology to ensure common understanding of issues and priorities
• Works with GRS colleagues and relevant cross-functional project team(s) members (i.e. Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal)
• Partners with EU colleagues, including GRS-in Country colleagues, Medical and Commercial colleagues, to provide an EU position
• Works directly or indirectly with external contacts in Regulatory Agencies within EU region, as well as relevant experts and key opinion leaders
• Ensures alignment with GRL and GRPL

Qualification skills

• Advanced Scientific Degree (M.D, Ph.D, Pharm.D, M.Sc). or equivalent experience in drug, device, development and/or commercialization
• A business qualification (MBA) may be useful Proven business management capabilities
• Demonstrable experience in drug and/or device development or relevant experience in the Pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Sciences/Health Authority and/or proven track record of success in negotiating with Health Authorities at EU regional level and in representing interests to internal and external stakeholders
• Relevant Global regulatory experience (more than one region)
• Demonstrated strategic thinking and ability to integrate strategies into actionable plans
• Proven ability to function autonomously at a senior level in a highly matrixed organization
• Has significant experience of the oncology therapeutic area, through prior regulatory experience; direct product development and/or academic training
• Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting CTAs, MAA
• Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management
• Presentation skills - Is effective in a variety of formal presentation settings; one- on-one, small and large groups, with peers, direct reports and senior manager
• Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations