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Your tasks and responsibilities
The primary responsibilities of this role, Director Global Regulatory Affairs Strategy, are to:
GRS is actively involved in 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.). 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;
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;
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 for developing the initial target labeling (and competitor labeling) in close cooperation with GRA Global Labeling;
Responsible for identifying 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;
Ensures 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;
Responsible for achieving assigned global Regulatory Milestones and owns the Regulatory risk assessment for these Milestones;
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;
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);
Leads a global regulatory team (GRT) and coordinates worldwide regulatory input into the global development plan for assigned projects. The GRT is chaired by the GRS with global responsibility;
Ensures that the target labeling, and Regulatory Strategy Plans address the needs of the specifically assigned region (Global/US/EU);
Responsible for creating and/or managing a strong network for assigned projects with the health authority in the assigned region, and other key regulatory influencers and stakeholders, that facilitates the incorporation of regulatory intelligence and influence into the regulatory project strategy with the goal to increase overall approval chances;
Responsible for building and maintaining an overview of available documentation for assigned projects via a database or equivalent tracking tool in close cooperation with Global Submission. This includes all regulatory documents needed to support and maintain Clinical Trial Authorizations (INDs, CTX, etc.) and/or Marketing Authorizations (NDAs, MAAs,NDSs, etc.) in line with current Regulatory standards and guidelines;
Responsible for leading or facilitating the BSP Global Review for assigned project submissions to finalize and approve Clinical trial (i.e. IND) and Marketing Application submissions dossiers (i.e. NDA) (not applicable for liaison role);
Responsible for maintaining the BSP global regulatory position for assigned projects in preparation and coordination of all responses to worldwide health authority deficiency letters. Actively monitors that the company meets all post-marketing commitments in close co-operation with the functions;
Co-ordinates all Regulatory matters with license partner in Joint Development Committees. Evaluates new strategic concepts and license opportunities for the product* (not applicable in liaison role) Review of promotional material on global level (Interface to promotional integration team);
Where applicable, coordinates the activities of a small group of Global Regulatory Managers assigned to major development projects.
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., M.D., D.V.M. or Pharm.D. in life sciences with 6+ years of industry experience in medical research activities of which minimum of 2 years include regulatory experience. Or MS degree with 10+ years industry experience in medical research activities of which minimum of 4 years include regulatory experience. Or BS degree with 12+ years industry experience in medical research activities of which minimum of 6 years include regulatory experience.
The incumbent must have expert knowledge of the region he / she will be responsible for (EMEA/ FDA regulations on Clinical trials applications and drug approval regulations). A working knowledge of foreign regulations as well as of adverse drug event reporting requirements is also required;
Broad experience and communications skills are required. The incumbent must be able to knowledgeably discuss and effectively deal with, as well as provide training, on issues such as product safety and drug regulation compliance with BSP medical staff, clinical investigators, marketing staff, quality assurance staff, BSP medical and coordination staff, FDA, EMEA and responsible individuals in other pharmaceutical companies.
Managerial abilities are required to direct and develop staff and to guide and implement international clinical compliance strategies and training, where applicable.
A thorough knowledge of company policies and procedures in drug development and maintenance is essential as well as sensitivity to the diverse cultures comprising the global Regulatory community.
Incumbent must have demonstrated originality in problem solving as applied to drug Regulatory issues and have skills and experience dealing with drug Health Authorities.
The position requires scientific and technical expertise, including the ability to develop robust regulatory plans covering all phases of drug development. Strong analytical skills are necessary to interpret regulatory data and make critical decisions. The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure.
Strong management skills are necessary for the leader of a global regulatory team operating in a matrix environment and, where applicable, coordination of a small group of Global Regulatory Managers.
Leadership, motivational, interpersonal and issue resolution skills are critical. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action, and a further level of complexity is added by virtue of working
across many cultures and time zones. In many cases, competing objectives will have to be harmonized and reconciled to achieve the overall objectives;
Must have well developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence-management skills;
In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection is also a plus.
The incumbent should have a working knowledge of medical procedures, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials would be a plus.
Due diligence experience-evaluate in licensing
Gene therapy experience
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