Director Global Regulatory Strategy

Employment Type

: Full-Time

Industry

: Miscellaneous



YOUR TASKS AND RESPONSIBILITIESThe 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 AREYour 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:Required Qualifications: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.Country: United StatesState: New JerseyLocation: WhippanyReference Code: 67512Functional Area:Regulatory AffairsEntry Level : Professional

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