Global Regulatory Strategist

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Global Regulatory Strategist**

**YOUR TASKS AND RESPONSIBILITIES**

This role 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. As the Global Regulatory Strategist for Combination Products, this position will provide relevant scientific and technical expertise to development programs that have high impact on Bayer s portfolio, for drug device combinations, cell and gene therapies, and digital assets. Integrating the local/regional regulatory requirements into the best and single global regulatory strategy requires broad global experience and efficient interaction with many multinational and multifunctional partners. The best global regulatory strategy is important in achieving early approvals with competitive labeling. The assessment of the probability of regulatory success has a major impact on the overall Probability of Technical Success (PTS) for a development project and thereby on the prioritization and commercial value of the project.
- Develop and implement robust global Regulatory strategies for complex/high impact programs for Combination Products in Bayer’s portfolio 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.).
- Collaborate with Global Regulatory Strategists on assigned programs that have regional and/or local responsibility to ensure integration of regional/local requirements into the overall Global Regulatory Strategy.
- Lead and/or participate on 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, Integrated Care, Medical Devices & eHealth, and Therapeutic Areas, 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.
- Clearly communicate recommended combination product strategies and changing regulatory requirements, including necessary adaptions to peers, senior management and cross functional teams.
- 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**
- Advanced scientific degree (e.g., PhD) in Biomedical Engineering, Pharmacology, Healthcare, or related discipline preferred, with several years of experience with local/global regulatory submissions for combination products
- MS degree in Biomedical Engineering, Pharmacology, Healthcare, or related discipline with extensive experience with local/global regulatory submissions for combination products.
- BS degree in Biomedical Engineering, Pharmacology, Healthcare, or related discipline with long term experience with local/global regulatory submissions for combination products.
- 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, 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.
- Experience with regulatory activities for cell and gene therapies or digital technologies (wearable devices, etc.) is preferred.
- 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