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Bayer is a global enterprise with core competencies in the fields of health care,
agriculture and high-tech polymer materials. As an innovation company, it sets trends
in research-intensive areas. Bayer’s products and services are designed to benefit
people and improve their quality of life. Bayer HealthCare combines the global
activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Its aim is to discover, develop, manufacture and market products that will
improve human and animal health worldwide. 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.
Global Regulatory Strategist (m/f)
YOUR TASKS AND RESPONSIBILITIES
• Develop regulatory strategy for assigned Medical Device projects
• Actively involved in decision making on all key development questions via an assessment
on the probability of regulatory success
• Develop the regional/local regulatory project goals from development through life cycle
• Represent the EU region in close cooperation with the lead Global Regulatory Strategist
(GRS) who is the Global Project Team (GPT) member
• Develop material including Design Dossier and Change Notification for regional/local
submission, guide the review process, check for accuracy, scientific consistency,
compliance to local and global Health Authority (HA) regulations and completeness of
submission
• Participate and lead a Global Regulatory Team (GRT) and provide regional/local
regulatory input into the global development plan of assigned projects
• Organize and drive preparation for meetings and teleconferences with local and global
HA officials
• Conduct regulatory due diligence on potential in-licensing opportunities
• Collect, review and analyze local and global agency guidelines and precedence, as well
as competitor information, in order to provide advice to project team
WHO YOU ARE
• Academic degree (Ph.D., DVM, Pharm D., M.Sc. or B.Sc.) in life sciences
• Long-term experience in medical device activities of which several years include local/global
regulatory experience
• Expert knowledge of medical devices and proven track record for products of this class
• Expertise in regional and local regulations as well as a working knowledge of global
regulations
• Excellent communication skills, verbal and written
• Strong analytical skills and ability to organize and direct diverse activities in a
Passion to innovate | Power to change
Country
Germany
Location
Berlin
Division
Bayer HealthCare
Contact us
Phone +49 214 30 99779
www.karriere.bayer.de
Reference Code
0000126789
Bayer welcomes applications from all
individuals, regardless of racial or
ethnic origin, skin color, nationality,
religion, philosophy, gender, age,
disability, appearance or sexual
identity. We are committed to treating
all applicants fairly and avoiding
discrimination.
changing environment
• Ability to work within a global team framework and a multi-cultural environment
• Very good leadership and project management skills, including cross-functional
communication, interpersonal and influence-management skills
• Being open-minded and challenging the status quo
• Business fluent in English, both written and spoken
YOUR APPLICATION
We offer a competitive salary in an international environment as well as excellent
opportunities for professional and personal development. If your background and personal
experience fits this profile, please send us your complete application at www.career.bayer.de,
submitting a cover letter, your CV and references as well as your salary expectation.
Passion to innovate | Power to change
Contact us
Phone +49 214 30 99779
www.karriere.bayer.de
Reference Code
0000126789