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.
Director Global Regulatory Strategy
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Director Global Regulatory Strategy, are to:
- Develop Regulatory Strategy for assigned projects by designing and assessing regulatory strategy options on a regional/global basis (as outlined in the Global Regulatory Plan);
- Be involved actively in decision making on all key development questions via an assessment on the probability of regulatory success;
- Develop the regional/global regulatory project goals from development through life cycle;
- Represent Global Regulatory Affairs on assigned global Project Teams;
- Develop submission materials for local and global submission, guide the review process, check for accuracy, scientific consistency, compliance to local and global Health Authority (HA) regulations and completeness of submission;
- Lead a global regulatory team (GRT) and coordinate worldwide regulatory input into the global development plan of assigned projects;
- Organize and drive preparations for meetings and teleconferences with local and global HA officials;
- Conduct regulatory due diligence on potential in-licensing 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 of Science with at least 10 years of experience in biomedical activities of which at least 5 years including local / global regulatory experience, or Master of Science with at least 8 years of experience in biomedical activities of which at least 3 years including local / global regulatory experience, or Ph.D. or D.V.M. or Pharm. D. in Life Sciences with at least 6 years of direct experience in biomedical research, of which at least 1 year includes local/global regulatory experience;
- 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;
- Scientific and technical expertise, including the ability to develop robust regulatory plans covering all phases of drug development. Strong analytical skills are necessary to interpret regulatory data and make critical decisions. The incumbent will be required 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;
- Strong management skills are necessary for the leader of a global regulatory team operating in a matrix environment and, where applicable, coordination of a small group of Global Regulatory Managers;
- Leadership, motivational, interpersonal and issue resolution skills are critical. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action, and a further level of complexity is added by virtue of working across many cultures and time zones. In many cases, competing objectives will have to be harmonized and reconciled to achieve the overall objectives.
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.
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.
State: New Jersey
Reference Code: 340483
Functional Area: Regulatory Affairs
Entry Level : Professional