Goettingen, Germany
103 days ago
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.

Grow with us – Your Responsibilities

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) 

What will convince us

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

What we offer

As a growing global life science company, stock listed on the DAX and TecDAX, Sartorius offers a wide range of 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 

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

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