Manager of Regulatory Affairs (x|f|m)
We are currently looking for a Manager of Regulatory Affairs (x|f|m) for the Regulatory Compliance department within Sartorius Stedim Biotech GmbH at our headquarters Goettingen (with the possibility to work remotely on a regular basis). With this position comes responsibility for steering and overseeing of regulation processes requiring governmental or other relevant external approvals, including the filing of necessary applications and handling all required interactions. As Manager of Regulatory Affairs (x|f|m) the goal is to ensure regulatory requirements are fulfilled in sustainable manner within the company and so to create the future with us.
Your t asks
Manage activities of Regulatory Affairs and prepare, review, edit and submit documents to the related authorities
Develop and implement regulatory operating guidelines and common work practices | strategies
Oversee and ensure compliance with regulatory procedures and work practices
Identify an optimal strategy for assigned projects and lead teams in examining regulatory strategy options
Proactively identify new regulations and implement appropriate regulatory strategies accordingly
Interface with (global) regulatory authorities & outside consultants and provide guidance to other regulatory personnel
Train, mentor and supervise regulatory employees, consultants and contractors and develop the team
Provide regulatory advice to multidisciplinary teams as Manager of Regulatory Affairs ( x|f|m )
Your qualifications
Successfully completed Master's degree in science within a relevant scientific discipline
Many years of professional experience in the medical device industry and | or the biotechnology industry
Experienced in managing a team providing active leadership
Deep knowledge in interpretation of regulations, guidelines, policy statements, etc. and in interfacing with relevant regulatory authorities
Expertise in the preparation of major regulatory submissions and understanding of applicable regulations
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including as well scientific as manufacturing staff
Strong organizational skills, including the ability to prioritize the own such as direct reports’ workload
Proven ability to work effectively and collaboratively in cross-functional and international teams
Excellent written and verbal communication skills as well in German as in English and willingness to travel (max. 10%)
Identification with our core values: Sustainability, Openness, Enjoyment and the motivation to work in a dynamic company
Our Benefits
Life Science & World Health: Social added value through passion for shaping the future of tomorrow
Open corporate culture: Characterized by diversity, team spirit and progress
People development opportunities: Training, coaching, leadership programs, etc., on a global level
Mobility benefits : Job ticket as well as car and eBike leasing benefits & free parking garage
Well-Being: Free gym & classes, as well as many health campaigns
Impressive campus: Open space offices & desk sharing culture as well as open air workplaces
IT hardware: Newest and powerful Apple products with many new collaboration features for daily business
Company
Sartorius as a listed company wants to simplify progress in the life sciences and biopharmaceutical industry. This enables scientific findings to be translated into new drugs and therapies faster and more efficiently, and gives more people access to better medicine. Nearly 16,000 employees at more than 60 production and sales sites worldwide are working towards this vision. Would you also like to contribute to our vision? Grow with us and benefit from the advantages of a global player.
Ready to join Sartorius?
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution. We are looking forward to receiving your application.