Director, Regulatory Strategy, Cell & Gene Therapy

Job Detail

Key Duties and Responsibilities:

Leads the development of regulatory strategy for assigned projects/regions in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents
Represents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy
Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership
Anticipates global regulatory changes and develops proactive strategy accordingly
Shapes the regulatory strategy for regulatory submission documents and Health Authority communications
Counsels and advises GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures and practices
Ensures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with current regulations and guidance
Manages project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time
Contributes to the continuous improvement of existing department processes and strategies, providing recommendations in area of expertise
Provides regulatory leadership to the GRA functional team(s) or projects with moderate resource requirements or complexity

Knowledge and Skills:

Experience in Regulatory Affairs strategy in assigned geographic region(s), including direct interactions with a variety of stakeholders
Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments. Advanced knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use.
Proficient knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals
Proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products.
Advanced skill in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development, and in leading productive health authority interactions, including well organized preparation of cross functional teams.
Actively uses expertise to develop others by providing coaching, guidance and mentoring.
A strong collaborative partner with cross-functional colleagues with the ability to build consensus through ability to present a clear and compelling case for ideas
Demonstrates excellent communication skills with ability to impact and influence the decisions of a team

Education and Experience:

Bachelor’s degree in Biology, Chemistry, or other related discipline
Typically requires 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs

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