The primary responsibilities of this role, Director Global Regulatory Strategy, are to:
Develops Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional/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;
Develops the regional/global regulatory project goals from development through life cycle;
Represents Global Regulatory Affairs on assigned global Project Teams;
Develops submission materials for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global HA regulations and completeness of submission;
Lead a global regulatory team (GRT) and coordinate worldwide regulatory input into the global development plan of assigned project;
Organizes and drives preparations for meetings and teleconferences with local and global HA officials;
Conduct regulatory due diligence on potential in-licensing opportunities.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Advanced technical degree Ph.D., DVM or Pharm D in life sciences with 4 years direct experience in biomedical research, of which 1-3 years include local/global regulatory experience in related TA area; or MS degree with 6 years of experience in biomedical activities of which 3-5 years include local/global regulatory experience; or BS degree with 10 years of experience in biomedical activities of which 5-10 years include local/global regulatory experience;
Expert knowledge of the regional HA regulations and advanced knowledge of global regulations. Demonstrated interactions with local 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;
Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners.
Internal Number: 67512
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
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