We are looking for a
GRA CMC Managerto lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management. In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner with technical and regulatory teams worldwide.
Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g.MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.
Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g.CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).
Preparation and review of CMC related information and documentationrequiredfor tenders, PSURs, DSURs, CCDS/productinformationand promotional materials.
Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
Is responsible fordevelopment and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, productchangesand relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.
Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
About CSL Plasma
CSL Plasma operates one of the world’s largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.
Learn more about CSL Plasma here https://www.cslplasma.com/ and CSL, CSL Behring, CSL Seqirus and CSL Vifor here https://www.csl.com/.
Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
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 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.
