Global Regulatory Affairs | Therapeutic Area: Immunoglobulins
As Regional Regulatory Lead (RRL), you will be responsible for defining and driving the regional regulatory strategy and its execution for a diverse portfolio of Immunoglobulin products across APAC, LATAM, and Partner Business markets.
In this highly visible and strategically important role, you will shape and implement regional regulatory strategies, ensure compliance with local and regional requirements, and actively contribute to global regulatory planning in close collaboration with the Therapeutic Area Lead.
Working closely with Local Regulatory Representatives and cross-functional stakeholders, you will support timely product approvals, maintain lifecycle compliance, and lead effective interactions with Health Authorities.
Key Responsibilities
As Regional Regulatory Lead, you will:
Act as the regional regulatory strategist for the assigned product portfolio, ensuring alignment with global priorities.
Develop and execute regional regulatory strategies, integrating local requirements and identifying efficient approval pathways.
Participate in Global Strategy Teams (GRAST) and contribute to global regulatory planning, including complex scientific assessments as required.
Oversee all regional regulatory activities, including new drug applications, renewals, variations, PSURs, and HA interactions.
Ensure high‑quality preparation of regulatory documentation and responses to Health Authority questions.
Build strong, collaborative relationships with Local Regulatory Representatives, Manufacturing, Supply Chain, Medical Affairs, and other internal partners.
Maintain constructive, influential interactions with Health Authorities to drive positive outcomes in collaboration with Local Regulatory Representatives,
Stay abreast of international and regional regulations relevant to CSL products, including rare diseases, orphan drugs, toll manufacturing, and reliance pathways.
Act as a regional subject matter expert, proactively identifying regulatory risks and providing clear, expert guidance to stakeholders.
Contribute to process improvement initiatives and support the development of training materials and best practices.
About You – Qualifications & Experience
You will be successful in this role if you bring:
A degree in Biological or Medical Sciences, Pharmacy, or a related field; postgraduate qualifications (e.g., in Drug Regulatory Affairs) are an advantage.
Minimum 5 years of regulatory experience in international markets, ideally within the pharmaceutical/biotech industry.
Strong understanding of scientific principles, pharmaceutical development, and GMP requirements.
Fluency in English (mandatory); additional languages such as Arabic, French, Spanish, or Russian are an asset.
Demonstrated ability to manage complex regulatory activities, influence stakeholders, and navigate diverse regulatory environments.
Why Join Us?
This is a unique opportunity to play a strategic role in bringing critical therapies to patients across dynamic and fast‑growing regions. You will join a global team committed to innovation, collaboration, and continuous improvement.
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.
