Deputy Director Global Regulatory Affairs Strategy

Posted on Nov 14, 2018 by JobLeads

Whippany, NJ 07981
Public Sector & Government
Immediate Start
Annual Salary
Full-Time
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. __________________________________________________ Apply online Deputy Director Global Regulatory Affairs Strategy Your tasks and responsibilities The primary responsibilities of this role, Deputy Director Global Regulatory Strategy, are to: * Be 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.); * Be responsible for achieving 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. * Ensure submission and approval of clinical trial applications 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), ensuring active feed-back from, and robust agreements/approvals with/by, regional and functional Regulatory Core Team (RCT) members, Bayer internal functions involved in the development and life cycle process as well as external regulatory advisors in academia; * Develop the initial target labeling (and competitor labeling) in close cooperation with Global Regulatory Affairs (GRA) Global Labeling; * 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; * Actively contributes 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 Product Development(PD) product goals; * Communicate and manage these regulatory measures in all major all major global markets via the Regulatory Core Team members and/or local Bayer regulatory departments; * Be responsible for achieving assigned global regulatory milestones and owns 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, keeping 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 Regulatory Affairs (RA) management; * Lead 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 a GPT member as well as Regional GRS); * Lead a Global Regulatory Team (GRT) and coordinate worldwide regulatory input into the global development plan for assigned projects. The GRT is chaired by the GRS with global responsibility; * Ensure that the target labeling, and Regulatory Strategy Plans address the needs of the specifically assigned region (Global/U.S./E.U.); * Be 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 facilitate the incorporation of regulatory intelligence and influence into the regulatory project strategy with the goal to increase overall approval chances; * Be 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 (Investigative New Drugs (INDs), CTX, etc.) and/or Marketing Authorizations (NDAs, MAAs, NDS , etc) in line with current Regulatory standards and guidelines; * Be responsible for leading or facilitating the Bayer Global Review for assigned project submissions to finalize and approve Clinical trial (i.e. IND) and Marketing Application submissions dossiers (i.e. NDA); * Be responsible for maintaining the Bayer global regulatory position for assigned projects in preparation and coordination of all responses to worldwide health authority deficiency letters; * Actively monitor that the company meets all post-marketing commitments in close co-operation with the functions; * Co-ordinate all Regulatory matters with license partner in Joint Development Committees; * Evaluate new strategic concepts and license opportunities for the product; * Review of promotional material on global level (Interface to promotional integration team); * Where applicable, coordinate 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: Required Qualifications: * Advanced technical degree (Ph.D., M.D., D.V.M. or Pharm.D. in life sciences with 10 years industry experience in medical research activities of which 2 - 5 years include global regulatory experience in related therapeutic area or 5 years of local regulatory experience in a highly drug-related country OR MS degree with 10 years industry * experience OR BS degree with 14 years industry experience of which 2 - 5 years of local regulatory experience in a highly drug related country; * Must have expert knowledge of the region he/she will be responsible for US, Europe, Middle East Africa/Food and Drug Administration (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; * Broad experience and communications skills; * 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 Bayer medical staff, clinical investigators, marketing staff, quality assurance staff, Bayer medical and coordination staff, EMEA/FDA and responsible individuals in other pharmaceutical companies; * Managerial abilities in order 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; * Must have demonstrated originality in problem solving as applied to drug Regulatory issues and have skills and experience dealing with drug Health Authorities; * 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; * 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; * 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; * Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence-management skills. Preferred Qualifications: * Working knowledge or experience in developing PRO Tools in collaboration with Health Authorities. * In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection; * A working knowledge of medical procedures, drug therapy, statistical concepts and the collection..... click apply for full job details

Reference: 559325249

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