General Summary:
The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible for overseeing the development and implementation of innovative global regulatory strategies for product development and commercialization of programs within the T1D portfolio. This position will manage a group of global/regional regulatory professionals with program leadership responsibilities. This role will play a major role in shaping cohesive regulatory strategy across the programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy.
Key Duties and Responsibilities:
- Leads the development of regulatory strategy for multiple projects in development (from FIH to post marketing application stage) within the T1D portfolio, representing regulatory on the senior cross-functional teams providing strategic input and innovative regulatory solutions and guidance for complex and/or critical topics.
- Ensures the global regulatory strategy for programs within the portfolio are consistent with corporate business objectives and negotiated with relevant health authorities as appropriate
- Works with global regulatory program leads and regional representatives to ensure unified regulatory input into cross-functional development teams, clinical programs, and commercial strategy
- Contributes to the review, authorship and quality of regulatory submission documents and Health Authority communications
- Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices
- Creates and assesses project plans and timelines and assigns and manages staff effectively to ensure all projects are appropriately prioritized and key goals are met on time. Plays a key role in developing career growth opportunities for staff
- Influences regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations
- Sponsors continuous improvement efforts on existing department processes and strategies, providing recommendations to shape the outcome. Provides recommendations for resource planning.
- As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.
Knowledge and Skills:
- Demonstrated technical and tactical expertise in regulatory affairs science including knowledge of regulatory frameworks and external environments. Expert knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use.
- Demonstrated expertise on research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals
- Expert proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products.
- Demonstrated advanced expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions
- Demonstrated advanced expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guides development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development.
- Ability to navigate ambiguity, demonstrate agility, communicate a strong understanding of the requirements, opportunities, risks and alternatives for developing and maintaining products in the assigned portfolio.
- Builds and sustains strategic partnerships across the organization, especially with cross functional leadership for assigned portfolio.
- Proactively remains up to date on scientific and clinical advances, competitive intelligence and changes in the regulatory environment that impact product development for assigned portfolio.
- Ability to articulate the organization’s strategic vision and core values, and successfully lead and contribute to improving the quality of internal regulatory policies, programs and initiatives.
- A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.
- Enterprise minded and capable of strategic thinking and proposing innovative solutions to regulatory problems
- Demonstrates excellent communication skills with ability to impact and influence decisions at all levels of the organization and ability to communicate with all levels within the company and act as liaison / representative both internally and externally
- Expert verbal and written communicator
- Able to provide regulatory leadership both functionally and in a matrix environment
- Actively pursues innovation and excellence and is able to motivate others to pursue these values
Education and Experience:
- Bachelor's degree in Biology, Chemistry, or other related discipline
- Typically requires 15 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 7 years of supervisory/management experience, or the equivalent combination of education and experience
