Associate Director, Global Regulatory Strategy - Oncology

Bayer U.S.
Whippany NJ
competitive compensation and benefits programs.
May 31, 2018
Jul 31, 2018
Career Fair Category
Career Fair

Associate Director, Global Regulatory Strategy - Oncology

Your tasks and responsibilities

The primary responsibilities of this role, Associate Director, Global Regulatory Strategy - Oncology, are to: 

  • Act as the primary interface between Bayer and the local Health Authority, e.g., Food and Drug Administration (FDA) in the US, European Medicines Agency (EMA) in Europe;
  • Organize and drive preparations for meetings and teleconferences with local Health Authority (HA) officials;
  • Represent a region in close cooperation with the Global Regulatory Strategist (GRS) who is the Global Project Team (GPT) member or may represent Global Regulatory Affairs (GRA) on assigned GPT.   May participate in GPT and working groups;
  • Develop the local regulatory project goals from development through life cycle;
  • Contribute to global regulatory strategy and project goals;
  • Participate on and may lead a Global Regulatory Team (GRT) and provide local regulatory input into the global development plan for assigned projects;
  • Compile and submit Investigative New Drug (IND) and Clinical Trial Applications (CTAs) to enable timely start of the clinical trials for the assigned development products with oversight from Lead GRS and supervisor;
  • Work with Lead GRS, supervisor, and Therapeutic Area (TA) head to develop submission materials for local HA, guide the review process, check for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission;
  • Collect, review and analyze competitor information, local and global Agency guidelines and precedence and provide advice to team with minimal supervision;
  • Be responsible for developing the global target labeling in close cooperation with GPT and GRA Global Labeling;
  • Provide guidance to other functions/staff to assure clinical trial programs are carried out in accordance with all regulations and applicable Bayer Standard Operating Procedures. Data from these trials should support product registration;
  • Provide regulatory risk assessment for project on a local basis and possibly global level and is able to support that input
  • Co-ordinate regulatory matters with license partners with the Lead GRS and TA supervisor.
  • 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., D.V.M. or Pharm D in life sciences with six years in medical research activities of which 1-3 years include local/global regulatory experience in related TA area, or M.S. degree with eight years of medical research activities of which 3-5 years include local/global regulatory experience, or B.S. degree with ten years of medical research activities of which 5-10 years include local/global regulatory experience;
  • Must have in-depth knowledge of the region he/she will be responsible for (EMA/FDA regulations on Clinical trials applications and drug approval regulations);
  • Familiarity with foreign regulations as well as of adverse drug event reporting requirements;
  • Excellent communication skills, verbal and written;
  • The ability to work within a global team framework and a multicultural environment;
  • Strong analytical skills are necessary to interpret regulatory data and make critical decisions;
  • Must 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.
  • Preferred Qualifications:

  • Advanced technical degree Ph.D., D.V.M. or Pharm D in life sciences;
  • 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;
  • Strong project management skills.
  • 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

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