The Director, Global Regulatory Strategist, Cell & Gene Therapy (CGT) Combination Products requires a Global Regulatory Expert who can lead Combination Product Asset Development projects to achieve global registration. The position will work within a team of Global Regulatory Strategists who have regional/local responsibility for their assigned programs.

YOUR TASKS AND RESPONSIBILITIES

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

• Develop and implement robust global Regulatory strategies for complex/high impact programs for Combination Products in Bayer’s portfolio including Cell and Gene Therapies (CGT) that leverage regulations in the US, EU and other target markets, and employ innovative approaches that enable fastest path to first cycle approval (e.g., core dossiers, IND, CTA, BLA, MAA, Technical Files, etc.);
• Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively collaborate with Bayer’s functions involved in combination product development to advance the assigned programs;
• Serve as the Global Regulatory Expert for the assigned programs and partner effectively with CMC, Product Supply (Medical Devices), Radiology, Therapeutic Areas & Labeling, and Bayer’s CGT subsidiaries (as applicable), to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities;
• Understand and communicate scientific principles and regulatory requirements relevant to global drug-device combination product development;
• Provide global regulatory assessments for requirements of drug-device combination products according to existing global guidelines and policies;
• Lead preparations and follow-up for project meetings and teleconferences with US/Can/EU health authority officials and aid in other country health authority meeting processes. 

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• A minimum of a BS degree is required;
• Expert knowledge of regional and global medical device regulations (e.g., EU MDR, Declarations of Conformity, CE Marking, ISO 13485, FDA Quality System Regulations, Design Control, 510(k), PMA etc.), particularly as they pertain to development of combination products; demonstrated interactions with local and global health authorities and notified bodies;
• Direct experience in developing regulatory strategies, creation of regulatory submission files obtaining FDA or EU clearance/approvals for combination products is required;
• Strong ability to communicate and negotiate effectively in English both verbally and in writing, and strong analytical skills are required;
• Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills, and collaboration skills;
• A clear understanding of cultural and business needs in leading a diverse team.

Preferred Qualifications:

• Advanced scientific degree (e.g., PhD) in Biomedical Engineering, Pharmacology, Healthcare, or related discipline preferred, with 6 years of experience with local/global regulatory submissions for combination products or a MS degree in Biomedical Engineering, Pharmacology, Healthcare, or related discipline with 8 years of experience with local/global regulatory submissions for combination products;
• Experience with regulatory activities for cell and gene therapies or digital technologies (wearable devices, etc.) is preferred.

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