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 tasks

• 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.​

About 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. www.sartorius.com/careers

to our Candidate Portal and thank you for your interest in working and growing with us. We look forward to receiving your application. You can check the status anytime in this portal.

Here you will find the best application tips from our HR team.

Information on the application process can also be found in this video and under FAQ & Contact (https://www.sartorius.com/en/company/careers/faq) .

In this brochure (https://www.sartorius.com/resource/static/celum/202114/23_EN_Candidate_Booklet_Digital_web.pdf) you will learn more about us as an employer and your career with us. For further insights, please visit the Sartorius Blog (http://www.sartorius.com/en/company/newsroom/blog) and our career website (http://www.sartorius.com/en/company/careers) .

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