Regulatory Affairs Manager (m/w/d) (Regulatory-Affairs-Manager/in)

• Randstad is one of the world's leading talent companies with the
• ambition to be the world's most equitable and specialized talent
• company. Through our "partner for talent" corporate strategy, we find,
• develop and connect specialized talents with companies - worldwide,
• locally and always at a high speed. We build high-quality, diverse,
• and agile teams, while individuals can enjoy a rewarding career path
• with equitable opportunities.
• Randstad Professional is one of Randstad's four specializations
• and focuses on the placement of specialists and managers in the
• future-oriented sectors of IT, Engineering, Life Science and Office.
• Are you an experienced regulatory professional looking to advance your
• career with an industry leader in Penzberg's thriving healthcare
• sector? Join an innovative team where you will independently drive
• complex global registration projects and help deliver groundbreaking
• solutions to patients worldwide. If you excel in an agile environment
• and thrive at the intersection of science and global compliance, we
• would love to welcome you aboard.

• Dossier & Submission Management: Lead the preparation and execution

• of complex regulatory submission dossiers for global markets while
• mentoring junior team members.

• Strategy & Compliance: Formulate region-specific regulatory

• strategies, anticipate compliance hurdles, and mitigate risks to
• accelerate market entry.

• Cross-Functional Stakeholder Engagement: Partner with key internal

• and external stakeholders—including R&D, QC, and international
• regulatory bodies—to drive alignment and support audits.

• Agile Leadership & Innovation: Champion continuous improvement,

• adopt digital regulatory tools, and influence cross-functional project
• teams to foster an inclusive, solution-oriented culture.

• Problem Solving & Decision Making: Independently resolve complex

• compliance issues, leverage data stewardship, and drive process
• optimization across all regulatory operations.

• Degree in Life Sciences, Data Science, or equivalent technical

qualification combined with relevant hands-on experience.

• At least 5 to 7 years of experience in Regulatory Affairs, R&D,

Quality, Operations, or Clinical environment.

• Proven track record of independently managing complex global

projects with minimal supervision.

• Fluent in spoken and written English with excellent communication

and conflict-resolution skills.

• Experience with Chinese regulatory affairs is strongly preferred.
• Attractive salary and long-term job security through affiliation

with the Group

• Up to 30 days vacation per year
• Contribution to company pension scheme after end of probationary

period

• Extensive social benefits, including Christmas and vacation bonuses