What are the responsibilities and job description for the Regulatory Affairs Manager CMC position at BioSpace?
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 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
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 company,CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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 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
- 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 isn't 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 company,CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.