Regulatory Affairs Manager CMC — CSL Behring
NewCHF 94'500 - 143'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 94'500 - 143'000
Role overview
Patients depend on a continuous, compliant supply of medicines reaching the markets that need them.
This role sits at the point where science, manufacturing, and regulation meet — translating CMC data into the submissions, change controls, and regulatory strategy that keep that supply moving without interruption.
As a Regulatory Affairs Manager CMC you will drive regulatory CMC strategy for your assigned products , spanning both development and commercial stages, working closely with colleagues across Global Regulatory Affairs CMC, R&D, Quality, and Global Operations.
- Patients depend on a continuous, compliant supply of medicines reaching the markets that need them.
- This role sits at the point where science, manufacturing, and regulation meet — translating CMC data into the submissions, change controls, and regulatory strategy that keep that supply moving without interruption.
Application process
- That collaboration shapes the high-quality, compliant CMC regulatory submissions you'll manage end-to-end— new marketing applications, clinical trial applications, variations, supplements, periodic compliance reports, and renewals — each one needing to be technically sound and built to withstand regulatory scrutiny.
- You'll also own the regulatory assessment of change controls within CSL's quality management system, working through the country-specific reporting requirements that determine how and when a change can be implemented.
- This is detailed, consequential work: getting it right protects both patients and product availability.
- Beyond the submissions themselves, you'll act as an authorized representative in direct dealings with health authorities for your portfolio — building the kind of relationships with regulators that make timely, constructive dialogue possible, and helping resolve ambiguity before it becomes a delay.
- You'll bring regulatory perspective into the evaluation of development opportunities and provide regulatory consultation to Global Operations, R&D, and IT teams designing processes and systems that need to hold up under compliance scrutiny.
- You'll also contribute to the regulatory policies, processes, and SOPs that keep CSL's practice current with international standards, and support oversight of outsourced regulatory activities to make sure external delivery meets the same bar as internal work. What you'll bring
- A bachelor's degree in biological or chemical sciences (or a related field); an advanced degree such as an MS or PhD is strongly preferred
- At least five years of progressively responsible regulatory experience in the pharmaceutical industry
Additional details
- You'll also contribute to the regulatory policies, processes, and SOPs that keep CSL's practice current with international standards, and support oversight of outsourced regulatory activities to make sure external delivery meets the same bar as internal work.
- It fuels our innovation day in and day out. By celebrating our differ
Notes and original content
- What you'll bring
- It fuels our innovation day in and day out.
- By celebrating our differ
