The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Director Global Regulatory Strategy In Vitro Diagnostics
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Director Global Regulatory Strategy In Vitro Diagnostic, are to:
Develop regulatory strategy for assigned In Vitro Diagnostic projects (IVD) by designing and assessing regulatory strategy options on a regional/global basis (as outlined in the global regulatory plan;
Ensure global regulatory plans support a precision medicine approach (e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies;
Be involved actively in decision making on all key development questions via an assessment on the probability of IVD regulatory success;
Develop the regional/global regulatory project goals from development through life cycle management;
Represent global regulatory affairs on assigned global IVD Project teams;
Develop submission materials for local and global IVD submission, guide the review process, check for accuracy, scientific consistency, compliance to local and global in vitro diagnostics regulations and completeness of IVD submission;
Lead a Global Regulatory Team (GRT) and coordinate worldwide regulatory input into the global development plan of assigned IVD projects;
Organize and drive preparations for meetings and teleconferences with local and global IVD HA officials;
Conduct regulatory IVD due diligence on potential partnership opportunities.
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:
Bachelor’s degree with at least 10 years of experience in biomedical activities of which at least five years include local/global regulatory experience OR a Master’s degree with at least eight years of experience in biomedical activities of which at least three years include local/global regulatory experience OR Ph.D., DVM OR Pharm.D. in life sciences with at least six years of direct experience in biomedical research, of which at least one year include local/global regulatory experience in related TA area;
Expert knowledge of the regional HA regulations and advanced knowledge of global regulations, demonstrated interactions with local health authorities;
Excellent communication skills, verbal and written, and strong analytical skills;
Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence management skills;
Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners.
Oncology Research or Oncology Regulatory Experience;
In-Vitro Diagnostics and/or Companion Diagnostic Experience in a pharmaceutical or device setting;
Experience interacting with Regulatory Authortities for IVD/CDX applications.
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. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.