As the Executive Regulatory Science Director, you are responsible for line managing approximately 10 Regulatory Affairs Directors (RADs). You will report directly to Vice President Regulatory CVRM. In this role, you will possess strategic leadership skills and have a deep understanding of global regulatory science, the overall drug development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders.
In this role, you will:
partner with and mentor the Regulatory Affairs Directors (RADs) aligning on global innovative regulatory strategies for our products and ensure it is consistent with the CVRM portfolio strategy
provide critical review and input on disease area or portfolio regulatory strategies, risk planning and mitigations
ensure disease area global regulatory strategy take into account key regional considerations
effectively represent the regulatory function in senior level interactions at internal governance technical review committees, key global health authority meetings and external partners
work in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging regulatory science, data and changes in the regulatory environment and advise senior management on CVRM (product) risks/mitigation activities accordingly
define and drive disease area regulatory policies and priorities within CVRM with internal and external stakeholders
lead budget management, resource planning and recruitment of staff. In addition, provide coaching, mentoring, skill development and performance feedback to RADs as well as other (regulatory) staff
review and approve high-level documents for global regulatory submissions as well as core prescribing information
lead complex non-drug projects (cross-functional or cross-SET area) on behalf of Global Regulatory Affairs (GRA) when necessary
ensure submission excellence framework is timely and consistently applied across projects including sharing best submission practices and knowledge and using existing tools
Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience (Advanced degree in a scientific discipline is preferred)
More than 10 years drug development experience
Experience in global regulatory strategy and submissions that have progressed through to registration
Significant experience in leading major health Authority interactions
Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority
Broad experience of the Cardiovascular, Renal and Metabolism therapeutic area, with preferably specific disease area regulatory sciences expertise
Experience in managing people in a matrixed organizational structure
Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities
Effective judgement and decision-making in complex business critical situations
Excellent collaboration, team working, oral and written communication skills
Willingness to undertake domestic and international travel