Manager of Regulatory Affairs (x|f|m) - Hybrid

Job Description

For our Regulatory Compliance department within Sartorius Stedim Biotech GmbH we are currently looking for a Manager of Regulatory Affairs (x|f|m), in full-time at our headquarters Goettingen (with the possibility to work remotely on an ad-hoc basis). With this position comes responsibility for steering and management of regulatory affairs team and processes requiring governmental or other relevant external compliance related communications and 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 comprehensive manner within the company and so to shape the future with us.

Responsibilities

• Manage activities of Regulatory Affairs and prepare, review, edit and submit documents to the related authorities.

• Develop, manage and implement operating documents, guidelines and common work practices | strategies.

• Oversee and ensure compliance with regulatory procedures and work practices.

• Manage the regulatory affairs team and ensure efficient operation of the function, including training, recruitment, performance management etc.

• Identify an optimal strategy for assigned projects and lead teams in examining regulatory strategy options.

• Proactively identify new regulations and/or upcoming changes, and implement appropriate regulatory strategies accordingly.

• Interface with (global) regulatory authorities & outside consultants and provide guidance to other regulatory personnel, plus provide regulatory advice to multidisciplinary teams as accountable.

• Train, mentor and supervise the team members, consultants and contractors and develop the team as Manager of Regulatory Affairs (x|f|m).

Qualifications

• Successfully completed Master's degree in a relevant scientific discipline, e.g. Biotechnology, Bioprocess Engineering, Chemistry or comparable.

• Many years of experience at supervisory level in regulated environment e.g. medical device | biotechnology industry.

• Competence and qualifications for the regulatory elements for medical device and ISO related certifications.

• Experienced in managing a team providing active leadership whilst proven ability to work effectively and collaboratively in cross-functional and international teams.

• 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 effectively deal with a variety of personnel of different areas and hierarchies.

• Strong organizational skills, including the ability to prioritize the own such as direct reports' workload.

• Business fluent in German and English (oral and written) as well as willingness to travel (approx. 10%).

• Strong identification with our core values: Sustainability, Openness, Enjoyment.

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

• Personal and Professional Development: Mentoring, leadership programs, Talent Talks, internal seminar offerings, coaching for managers.

• Work life balance: Remote options, flextime, flexible work schedules, sabbaticals.

• Large, modern campus: Open office spaces, terraces, company restaurant with vegetarian and vegan options, cozy Italian bistro with ice cream sales, fitness studio and daycare center.

• Making an impact right from the start: Comprehensive onboarding, including a virtual online platform even before joining, Welcome Workshops, "buddy" as point of contact.

• Travel benefits: Car leasing, bike leasing, large free parking garage, good bus connections.

• Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics, such as coaching, agile working and business women network.

JBRP1_DE