Director, Oncology Regulatory Affairs Strategy

Whippany, NJ, United States
Apr 16, 2018
Required Education
Bachelors Degree
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, Director, Oncology Regulatory Affairs Strategy, are to:

  • Make decisions 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.);
  • Achieve assigned regulatory project goals, milestones and labeling, from development through life cycle;
  • Represent worldwide Regulatory Affairs on assigned Global Project Teams or represent a region in close cooperation with the Global Regulatory Strategist (GRS) who is the Global Project Team (GPT) member;
  • Ensure submission and approval of clinical trial applications to enable timely start of the clinical trials for the assigned development products;
  • Provide regulatory advice on clinical trial design based on competitor intelligence and guidelines and Agency meeting strategy for evaluation of major clinical trials;
  • Design and assess 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, 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 GRA Global Labeling;
  • Identify overall Regulatory direction for appropriate development plans and optimized approval chances of the agreed target labeling;
  • Own and voice 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 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 all major global markets via the Regulatory Core Team members and/or local Bayer regulatory departments;
  • Achieve assigned global Regulatory Milestones and owner of the Regulatory risk assessment for these Milestones;
  • Communicate 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;
  • 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 (GRASC , ERMM as appropriate);
  • Lead the development of the Briefing document for the Health authority meeting;
  • Represent Global Regulatory Affairs at major Board of Health (BoH) meetings for assigned projects (GRS who is GPT member as well as Regional GRS);
  • Lead a global regulatory team (GRT) and coordinate world-wide regulatory input into the global development plan for assigned projects;
  • Ensure that the target labeling, and Regulatory Strategy Plans address the needs of the specifically assigned region (Global/US/EU);
  • Create and/or manage 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;
  • Build and maintain an overview on available documentation for assigned projects via a database or equivalent tracking tool in close cooperation with Global Submission, which 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;
  • Lead or facilitate 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) (not applicable for liaison role);
  • Maintain the Bayer global regulatory position for assigned projects in preparation and coordination of all responses to worldwide health authority deficiency letters and monitor the company meets all post marketing commitments in close co-operation with the functions;
  • Coordinate all Regulatory matters with license partner in Joint Development Committees;
  • Evaluate new strategic concepts and license opportunities for the product;
  • Review promotional material on global level (Interface to promotional integration team);
  • Coordinate the activities of a small group of Global Regulatory Managers assigned to major development projects.

This position is eligible for US Domestic Relocation

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:

  • Bachelor's 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 or;
  • Master's degree with 12 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;
  • Working knowledge of foreign regulations as well as of adverse drug event reporting requirement;
  • Broad experience and communications skills as 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 Bayer medical staff, clinical investigators, marketing staff, quality assurance staff, Bayer medical and coordination staff, FDA, EMEA and responsible individuals in other pharmaceutical companies;
  • Managerial ability to direct and develop staff and to guide and implement international clinical compliance strategies and training;
  • Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills;
  • Thorough knowledge of company policies and procedures in drug development and maintenance is essential;
  • Sensitivity to the diverse cultures comprising the global Regulatory community;
  • 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 regulatory skills to interpret regulatory data and make critical decisions;
  • Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure;
  • Strong management skills for the leader of a global regulatory team operating in a matrix environment and coordination of a small group of Global Regulatory Managers Strategy Leadership;
  • Motivational, interpersonal and issue resolution skills;
  • Skilled in gathering decision information, negotiation and communicating decisions and action, and a further level of complexity is added by virtue of working with many cultures and time zones. In many cases competing objectives will have to be harmonized and reconciled to achieve the overall objectives;
  • Managerial know-how involves the ability to lead a dynamic, energized and creative work team. The incumbent must provide the team with clear vision, direction, and purpose;
  • Understanding of different cultures and knowledge of Human Resource practices.

Preferred Qualifications:

  • Advanced technical degree Ph.D., MD, DVM or Pharm D is preferred in life sciences 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 with 3 of these years' experience in a country with greater responsibility(versus highly regulated country);
  • In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection;
  • Working knowledge of medical procedures, drug therapy, statistical concepts and the collection, computerization and reporting of data collected in clinical trials.
  • Oncology experience is preferred. We will consider candidates with experience in other therapeutic areas



Your application

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/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country: United States
Location: NJ-Whippany