The Senior Director Global Regulatory Strategist, Cell and Gene Therapy (CGT) requires a Senior Global Regulatory Expert who can lead complex CGT Development projects to achieve global registration. The position will lead the Global Regulatory Team for complex/high priority programs, including a team of Global Regulatory Strategists who have regional/local responsibility for the assigned program.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Director Global Regulatory Strategist, CGT, are to:

• Have accountability for developing robust Global Regulatory Strategy for complex/high impact CGT programs in the R&D portfolio that leverages accelerated regulatory approval pathways and other innovative strategies that enable fastest path to first cycle approval;
• Provide guidance and oversight to Global Regulatory Strategists on assigned program that have regional and/or local responsibility to ensure integration of regional/local requirements into the overall Global Regulatory Strategy;
• Serve as the Global Regulatory Expert for the assigned program and partners effectively with the Head of Clinical Development Therapeutic Area, Global Program Head, Global Clinical Leader (GCL)/Early Clinical Leader (ECL), Global Project Leader (GPL)/Early Project Leader (EPL) and the Biomarker Leader to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities;
• Effectively collaborate with Bayer’s Cell and Gene Therapy (CGT) subsidiary companies to advance co-development programs.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• A minimum of a BS degree in life sciences is required;
• Medical Research activities including local/global regulatory experience in the Cell & Gene Therapy (CGT);
• Expert knowledge of the regional and global regulations, particularly as they pertain to development of CGT products; demonstrated interactions with local and global health authorities;
• Excellent communication skills, verbal and written, and strong analytical skills are required;
• Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills;
• A clear understanding of cultural and business needs in leading a diverse team.

Preferred Qualifications:

• Advanced technical degree, Ph.D. in molecular biology or related discipline preferred, with 8 years in medical research activities of which 3-5 years include local/ global regulatory experience in CGT area, or MS degree in molecular biology or related discipline with 10 years of medical research activities of which 5-7 years include local/global regulatory experience with 3-5 years in the CGT area.

This posting will be available for application until at least: 4/8/25.