The primary responsibilities of this role, Director Global Regulatory Strategy, Oncology are to:
Work on decision making on all key development questions as a member of the project team (as all decisions impact the regulatory dossier and approval processes, i.e. preclinical and clinical study and program designs, licensing, etc.), be responsible for achieve assigned regulatory project goals, milestones and labeling, from development through life cycle, represent worldwide regulatory affairs on assigned global project teams or represents a region in close cooperation with the Global Regulatory Strategist (GRS) who is the Global Program Team (GPT) member;
Be responsible to ensure submission and approval of clinical trial applications/IND to enable timely start of the clinical trials for the assigned development products, give regulatory advice on clinical trial design based on competitor intelligence and guidelines and agency meeting strategy for evaluation of major clinical trials;
Be responsible for the 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), ensure active feedback from, and robust agreements/approvals with/by, regional and functional RCT members, Bayer Health Care (BHC) internal functions involved in the development and life cycle process as well as external regulatory advisors in academia, be responsible for developing the initial target labeling (and competitor labeling) in close cooperation with Global Regulatory Affairs (GRA) Global Labeling, be responsible for identifying the overall regulatory direction for appropriate development plans and optimized approval chances of the agreed target labeling;
Own the regulatory risk assessment in alignment with GRA management, keep abreast of changes in the regulatory environment for the project to anticipate necessary adaptations;
Contribute actively to strong issue management as a member of an appropriate sub-team, ensure early identification of major regulatory issues relating to clinical, technical, strategic or operational information impacting successful clinical trial authorizations, and/or marketing authorizations applications/approvals for assigned projects;
Identify corrective regulatory measures and immediate actions required in case of deviations jeopardizing global PD product goals;
Communicate and manage these regulatory measures in all major global markets via the regulatory core team members and/or local BHC regulatory departments;
Be responsible for achieving assigned global regulatory milestones and own the regulatory risk assessment for these milestones;
Be responsible for all communication with the regional health authority in the assigned region for his/her specific projects, keep track of all communications and requests in appropriate contact reporting databases and ensure appropriate internal and external communication of all regulatory relevant issues;
Develop the health authority meeting plan for validation of development programs at different stages in close co-operation with GPT and RCT in alignment with RA management, lead the development of the briefing document for the health authority meeting, be responsible for represents global regulatory affairs at major Board of Health (BoH) meetings for assigned projects (GRS who is GPT member as well as regional GRS, organize and drive preparations for meetings and teleconferences with local and global HA officials;
Lead a global regulatory team (GRT) and coordinate world-wide regulatory input into the global development plan for assigned projects, the GRT is chaired by the Lead GRS with global responsibility, ensure that the target labeling, and regulatory strategy plans address the needs of the specifically assigned region;
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:
Bachelor’s degree with at least 10 years of medical research activities of which at least five years include local/global regulatory experience OR Master’s degree with at least eight years of medical research activities of which at least three years include local/global regulatory experience OR Advanced technical degree Ph.D., D.V.M or Phar.D. in life sciences with at least six years in medical research activities of which at least one year include local/ global regulatory experience in related TA area;
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;
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. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans