Global Regulatory Strategist - Oncology

Bayer HealthCare Pharmaceuticals is committed to discovering, developing and marketing novel therapies and treatment programs that improve lives and create a better tomorrow for people around the world. An opportunity in Global Regulatory Affairs for a Assoc. Global Regulatory Strategist or Deputy Director of RA Strategy is currently available at our Montville, NJ facility. SummaryDescription:• The position will be functioning within a Therapeutic Area (Oncology) structure: The position will have responsibility for planning and managing global regulatory drug activities for major projects within an specific therapeutic area necessitating the coordination of a team of global regulatory manager strategy. This includes: achieving submission and approval of new chemical entities and oversight of regulatory activities designed to optimize the net present value of assigned marketed products. • Will be responsible for all communications with a specified regional Health Authority (EU Agencies including EMEA or FDA) for the assigned products. Major Responsibilities but not limited to: 1. GRS is actively involved in decision making on all key development questions as 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.) He/she is responsible for achieving assigned regulatory project goals, milestones and labeling, from development through life cycle. Represents worldwide Regulatory Affairs on assigned Global Project Teams or represents a region in close cooperation with the GRS who is the GPT member. 2. Responsible to ensure submission and approval of clinical trial applications to enable timely start of the clinical trials for the assigned development products. He/she gives Regulatory Advice on Clinical Trial design based on competitor intelligence and guidelines and Agency meeting strategy for evaluation of major clinical trials 3. 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), ensuring active feed-back from and robust agreements/approvals with/by regional and functional RCT members, BSP internal functions involved in the development and life cycle process as well as external regulatory advisors in academia. Responsible to develop the initial target labeling (and competitor labeling) in close cooperation with GRA Global Labeling. Responsible to identify the overall Regulatory direction for appropriate development plans and optimized approval chances of the agreed target labeling. Owns and clearly voices the Regulatory Risk assessment in alignment with GRA management. Keeps abreast of changes in the Regulatory environment for the project to anticipate necessary adaptations. Actively contributes to strong Issue Management as a member of an appropriate sub-team.4. Ensuring 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. Identifies corrective regulatory measures and immediate actions required in case of deviations jeopardizing global PD product goals. Communicates and manages these regulatory measures in all major all major global markets via the Regulatory Core Team members and/or local BSP regulatory departments. 5. Responsible for achieving assigned global Regulatory Milestones and owner of the Regulatory risk assessment for these Milestones 6. Responsible for all communication with the regional health authority in the assigned region for his/her specific projects, keeping track of all communications and requests in appropriate contact reporting databases and ensuring appropriate internal and external communication of all Regulatory relevant issues.7. Develops 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 (GRASC, ERMM as appropriate). Leads the development of the Briefing document for the Health authority meeting he/she is 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).Position Requiremetns:• Assoc Director Level: Ph.D., Pharm.D., or M.D. or the equivalent education with at least 4-6 years industry/FDA regulatory experience, or an M.S. degree in life sciences with 10-12 years of proven experience with a record of consistently good performance. Intense familiarity with and knowledge of medical/legal problems related to the regulatory area of responsibility. The individual must have demonstrated originality and problem solving ability as applied to all aspects of regulatory affairs and extensive experience with knowledge of FDA Divisions and concepts.• Deputy Director Level: Advanced technical degree (Ph.D., MD, DVM or Pharm D in life sciences preferred) with 10 years industry experience of which 5 years include global regulatory experience in related therapeutic area or 5 years local regulatory line management experience in a highly drug-regulated country or 3 years experience in regulatory positions of progressively greater responsibility. Or MS degree with 12 years industry experience or BS degree with 14 years industry experience of which 5 years include global regulatory experience in related therapeutic area or 5 years of local regulatory experience in a highly drug-regulated country.Analytical, Medical Terminology, Project Coordination, Strategic Planning, Compliance, Regulatory, Regulatory Reporting, Documentation, Pharmaceuticals