Associate Director, Global Regulatory Strategy (Remote)

Bayer
Bayer offers a competitive compensation package. Benefits include health care, vision, dental, retirement, PTO, sick leave, Life Insurance Pet Insurance, etc.
United States, New Jersey, Whippany
Sep 10, 2024
In Bayer's Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials. The primary responsibilities of this role, Associate Director, Global Regulatory Strategy are to: Develop Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional and global basis (as outlined in the Global Regulatory Plan). Actively involved in decision making on all key development questions via an assessment on the probability of regulatory success. Create the local and global regulatory project goals from development through life cycle. Represent Global Regulatory Affairs on assigned global Project Teams. Develop submission materials for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global Health Authority regulations and completeness of submissions. Lead a global regulatory team (GRT) and coordinate worldwide regulatory input into the global development plan of assigned projects. Organize and drive preparations for meetings and teleconferences with local and global Health Authority officials: Conduct regulatory due diligence on potential in licensing opportunities. WHO YOU ARE Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: Required Qualifications: Ph.D., DVM or PharmD in life sciences. Expert knowledge of the regional Health Authority regulations and advanced knowledge of global regulations demonstrated interactions with local health authorities. Strong communication (written and verbal) and analytical skills are essential. Demonstrated leadership and project management skills, including cross functional communication, interpersonal and influence management skills. Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners. Preferred Qualifications: Ph.D., DVM or Pharm D with 6 years of experience in medical research activities of which 1-3 years should include local/ global regulatory experience in related area, or MS degree with 8 years of medical research activities of which 3-5 years should include local/global regulatory experience, or BS degree with 10 years of medical research activities of which 5-10 years should include local/global regulatory experience or an equivalent combination of education and experience. #LI-AMSUS