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

Sartorius AG; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in biotechnology is seeking a Manager of Regulatory Affairs to lead the regulatory compliance team. This role involves managing regulatory submissions, ensuring compliance, and mentoring team members. The position offers remote work flexibility and a collaborative culture.

Leistungen

Personal and professional development opportunities

Work-life balance options

Comprehensive onboarding support

Travel benefits

Collaborative culture

Qualifikationen

• Extensive supervisory experience in regulated environments.
• Experience preparing major regulatory submissions.

Aufgaben

• Manage activities of Regulatory Affairs and submit documents to authorities.
• Develop and implement operating documents and strategies.
• Oversee compliance with regulatory procedures.

Kenntnisse

Leadership

Interpersonal Skills

Organizational Skills

Collaboration

Ausbildung

Master's degree in a relevant scientific discipline

Jobbeschreibung

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 in Goettingen, with the possibility to work remotely on an ad-hoc basis.

This position involves steering and managing the regulatory affairs team and processes, including external compliance communications and approvals, filing applications, and handling interactions with authorities. The goal is to ensure comprehensive regulatory compliance within the company and to shape the future with us.

Your Responsibilities

• Manage activities of Regulatory Affairs and prepare, review, and submit documents to authorities.
• Develop, manage, and implement operating documents, guidelines, and strategies.
• Oversee compliance with regulatory procedures and work practices.
• Manage the regulatory affairs team, including training, recruitment, and performance management.
• Identify optimal strategies for projects and lead teams in regulatory strategy development.
• Proactively monitor and implement strategies for new or upcoming regulations.
• Interface with global regulatory authorities and consultants, providing guidance and advice.
• Train, mentor, and supervise team members and develop the team as Manager of Regulatory Affairs.

What will convince us

• Master's degree in a relevant scientific discipline (e.g., Biotechnology, Chemistry).
• Extensive supervisory experience in regulated environments like medical devices or biotechnology.
• Qualifications in regulatory elements for medical devices and ISO certifications.
• Experience managing teams and working collaboratively in international settings.
• Deep understanding of regulations, guidelines, and authority interactions.
• Experience preparing major regulatory submissions.
• Strong interpersonal and organizational skills.
• Business fluency in German and English; willingness to travel (~10%).
• Alignment with core values: Sustainability, Openness, Enjoyment.

What we offer

Sartorius offers a wide range of benefits, including:

• Personal and professional development opportunities.
• Work-life balance options such as remote work, flextime, and sabbaticals.
• A modern campus with various amenities.
• Comprehensive onboarding and integration support.
• Travel benefits like leasing options and parking.
• A welcoming, collaborative culture with numerous community groups.

About Sartorius: We contribute to fighting diseases by translating scientific discoveries into medicines faster, helping therapeutics reach patients worldwide.

We seek ambitious team players and creative minds eager to make an impact in a dynamic global environment. Join us and be part of the solution. We look forward to your application.