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YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Regional Regulatory Manager, are to:
Acts as an interface between Bayer and the local Health Authority (HA).
Organize and drives preparations for meetings and teleconferences with HA officials to discuss compliance matters or issues that may arise during the development of a new product;
Drive development, completion, and submission to HA of any materials required for such meetings;
Submit regulatory information to the HA;
Review HA submissions to assure compliance with HA regulations;
Review and determines the applicability of supporting documentation for inclusion in regulatory submissions for accuracy, completeness, and scientific consistency;
Work closely with the GRS for the assigned product/project, as well as Global Clinical, Medical Affairs, Drug Safety, Quality Assurance, and other functions to monitor product related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices;
Provide guidance to other functions /staff to assure that clinical trial programs are carried out in accordance with all regulations and Bayer Standard Operating Procedures, so that data from these trials can be used to prepare high quality, approvable submissions and that Bayer or an investigator can withstand HA inspection;
Participate in the Global Regulatory Team to provide input for all phases of drug development for investigational products and/or licensed projects, contributing to the development and implementation of the Global Regulatory Plan, particularly with regard to addressing local HA requirements and the needs of the local market;
Provide local region-specific input to the GRS for discussion at Global Project Teams for a particular investigational or licensed product;
Participate in ad hoc Global Project Team sub-teams or working groups as invited by the Global Project Team;
Interact with responsible departments and functions to provide input to the GRS in support of the collection, review, and assembling of the scientific (preclinical, clinical, and manufacturing) and administrative sections of submissions to regulatory agencies for a particular investigational or licensed product;
Interact with Company Partners (including marketing partners and contract manufacturers) and Consultants for various regulatory matters as needed;
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;
Review promotional materials on global level (Interface to promotional integration team).
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 OR; MS with one year of experience in biomedical research activities OR; BS with four years of experience in biomedical activities;
Familiarity with local Health Authority (HA) regulations (FDA or EMA), especially as they apply to preclinical and clinical disciplines to support filings is desirable;
Desirable knowledge of medical procedures, drug therapy, statistical concepts, and the collection, computerization and reporting of data collected in clinical trials;
Good communication skills, verbal and written, are imperative;
Ability to work within a global team framework and a multicultural environment is required;
Strong analytical skills are necessary to interpret regulatory data and make critical decisions;
Supervision: Manages and coordinates regulatory projects, works independently with moderately high supervision.
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