Manager Regulatory Affairs (m/f/d)

Are you a seasoned regulatory professional looking to make a real impact? This opportunity invites you to leverage your expertise in regulatory affairs while driving meaningful contributions to the healthcare industry. You'll play a vital role in ensuring the successful approval and lifecycle management of pharmaceutical products in both national and international (EU and non-EU) markets.

What You’ll Do

In this dynamic role, you’ll:

• Lead Regulatory Submissions: Prepare, manage, and oversee documentation (Modules 1–5) for national and international product approvals, ensuring timely and compliant submissions.
• Drive Pharmaceutical Documentation Excellence: Create, update, and maintain pharmaceutical documentation (Modules 2.3 and 3), renewals, and variations in close collaboration with global partners.
• Collaborate on Packaging & Compliance: Develop and update packaging texts while ensuring strict compliance with regulatory guidelines.
• Be a Project Coordinator: Manage critical development projects, coordinate stability programs, and liaise with both internal departments and external laboratories.
• Support Development Projects: Provide regulatory expertise to guide product development and approval strategies.
• Coordinate Across Borders: Manage regulatory activities and approvals across diverse markets, including EU and non-EU regions.
• Build Strategic Relationships: Cultivate and maintain strong connections with national and international regulatory authorities, ensuring smooth communication and compliance.
• Ensure Guideline Adherence: Review and validate documentation from internal and external teams to meet regulatory standards.
• Lead Change Management: Oversee change control processes, CAPAs, and PQR coordination to ensure product and process integrity.

What You Bring to the Role

We’re seeking a passionate and detail-oriented professional with:

• A degree in a natural science field (e.g., Chemistry, Pharmacy, Biology, Medicine) or equivalent qualifications.
• Proven experience in pharmaceutical regulatory affairs, including medical device regulations (MDD and MDR).
• Fluency in German and English, both written and spoken.
• Proficiency with MS Office and the ability to adopt new tools and systems.
• An organized, reliable, and collaborative mindset with a commitment to quality and precision.

Why This Role?

Here’s what makes this opportunity unique and rewarding:

• Make an Impact: Your work directly contributes to bringing innovative healthcare solutions to market.
• Join a Thriving Organization: Be part of a forward-thinking company with a long-standing reputation for innovation and growth.
• Global Reach: Engage with diverse markets and broaden your professional scope.
• Collaborative Culture: Work in a supportive environment that values teamwork, trust, and open communication.
• Personal and Professional Growth: Take on diverse challenges that help you build expertise and advance your career.

If you’re ready to take your regulatory career to the next level in an environment that values your skills and contributions, this role is the perfect match!