The primary responsibilities of this role, Associate Director Global Regulatory Strategy, are to:
Act as the primary interface between Bayer and the local Health Authority (HA), e.g., FDA in the US, EMA in Europe;
Organize and drive preparations for meetings and teleconferences with local HA officials;
Represent a region in close cooperation with the Global Regulatory Strategists (GRS) who is the Global Project Team (GPT) member or may represent Global Regulatory Affairs (GRA) on assigned GPT;
Participate in Global Project Team 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 Investigational New Drugs (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;
Develop 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 based on regulatory precedence and product characteristics;
Co-ordinate regulatory matters with license partners with the Lead GRS and TA supervisor.
Domestic relocation assistance is offered for this position
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., D.V.M. or Pharm.D.) in life sciences with four (4) years in medical research activities of which one (1) to three (3) years includes local/global regulatory experience in related therapeutic area, M.S. degree with six (6) years industry experience of which one (1) to three (3) years include local/global regulatory experience, or B.S. degree with eight (8) years industry experience of which three (3) to five (5) years of 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;
Must have working knowledge of medical procedures, drug therapy, statistical concepts and the collection and computerization.
In-depth knowledge, domestic and foreign, of clinical trial methodology, clinical auditing procedures, and drug safety data collection;
In-depth knowledge of reporting of data collected in clinical trials;
Strong management skills;
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 be able 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.
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.