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 a 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.

• 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 scientific and manufacturing staff.

• Strong organizational skills, including the ability to prioritize own workload as well as that of direct reports.

• Proven ability to work effectively and collaboratively in cross-functional and international teams.

• Excellent written and verbal communication skills in both German and 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.