Bayer Deputy Director, Global Regulatory Strategist, Oncology in Whippany, NJ, New Jersey
Your tasks and responsibilities
The primary responsibilities of this position, Deputy Director Global Regulatory Strategist Oncology , are to: •The position is responsible for the development, alignment, and implementation of regulatory strategies to ensure earliest submissions and first cycle approvals with target labels for the assigned development projects on a global basis. Further, the position is in charge for assessing and aligning the probabilities for regulatory success for the assigned development projects. •Develops 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. •Develops the local and 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. •Leads a global regulatory team (GRT) and coordinates worldwide regulatory input into the global development plan of assigned projects. •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 preferred with 6 years in medical research activities of which a minimum of 1 year including local/ global regulatory experience in oncology or a related TA, or MS degree with 8 years of medical research activities of which a minimum of 3 years include local/global regulatory experience in oncology or a related TA, or BS degree with 10 years of medical research activities of which a minimum of 5 years include local/global regulatory experience in oncology or a related TA. •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
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled