As a Regulatory Affairs Manager at SLS Europe, your responsibilities will include:

• Develop and implement global regulatory strategies in support of product development, clinical trials, manufacturing, and market authorisations.
• Coordination, submission, and management of national and international approval procedures (e.g., CTAs, INDs, MAAs) to European, U.S., and other international competent authorities.
• Preparation, review and revision of documentation for regulatory applications (e.g. clinical, non-clinical, quality dossier/CMC, product information) in close collaboration with Subject Matter Experts.
• Lifecycle and submission management of marketing authorisations.
• Handling regulatory activities within the framework of change control procedures.
• Serve as liaison with regulatory authorities, coordinating meetings, responding to inquiries, and managing timely follow-ups.
• Collaborate closely with internal and external cross-functional stakeholders to align regulatory activities with product development milestones.
• Monitor evolving regulatory requirements and ensure that internal processes and documentation remain compliant and up-to-date.
• Document management and compilation of dossiers in eCTD format.

To thrive in this role, you should have:

• Advanced degree (Ph.D. preferred, or Master’s) in life sciences (e.g. biology, medicine, pharmacy).
• Professional experience in regulatory requirements and legislation.
• Several years of experience in the pharmaceutical industry.
• Proven track record in preparing and managing regulatory submissions and successful interactions with regulatory authorities (EMA, FDA, etc.).
• Deep understanding of global regulatory frameworks, guidelines (e.g. ICH, WHO), and GMP/GCP requirements.
• Excellent English skills, both written and spoken.
• Willingness to travel internationally (approximately 4 – 8 times per year).
• Proficiency in common software packages (e.g. Microsoft Office), as well as familiarity with regulatory submission tools (e.g. eCTD software).
• Self-organization, structured and precise working methods, and social competence.
• Strong project management and communication skills, teamwork, flexibility, and a performance- and goal-oriented work approach.

In return for your expertise and dedication, SLS Europe provides:

• The opportunity to contribute to our mission of providing accessible, life-saving medications globally.
• Hands-on involvement in innovative and challenging national and international regulatory projects for vaccines, biologics, and other advanced therapies.
• A diverse, international team environment that fosters knowledge sharing, mutual support, and professional growth.
• A comprehensive onboarding program, targeted training, and ongoing mentorship to ensure your success.
• Professional development opportunities through internal and external training.
• A competitive compensation package and benefits that reflect our commitment to sustainability and employee well-being.

Serum Life Science Europe GmbH
Dr. Leander Grode, CEO
Ahrensburgerstr Str. 1
30659 Hannover
+49 (511) 1699080
application@sls-eu.com