Regulatory Affairs Manager CMC

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. That collaboration shapes the high-quality compliant CMC regulatory submissions youll 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.

Youll also own the regulatory assessment of change controls within CSLs 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 youll 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. Youll 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.

Youll also contribute to the regulatory policies processes and SOPs that keep CSLs 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 youll bring

• A bachelors 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
• A solid technical grounding in the global regulations and standards governing drug product development manufacturing registration and lifecycle management
• Experience authoring and managing regulatory CMC submissions
• The ability to work effectively within a matrixed cross-functional structure
• Clear confident communication of regulatory positions whether in a technical review with internal stakeholders or a discussion with a health authority
• Sound judgment under ambiguity: the ability to weigh incomplete information draw on precedent and make a well-reasoned call when the picture isnt complete

CSL Vifor is a global partner of choice for pharmaceuticals and innovative leading therapies in irondeficiency and nephrology. We specialize in strategic global partnering in-licensing and developing manufacturing and marketing pharmaceutical products for precision healthcare aiming to help patients around the world lead better healthier lives. Headquartered in St. Gallen Switzerland CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent companyCSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

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