CSL
Regional Regulatory Lead - APAC, LATAM and Partner Business Regions
🇨🇭Zürich, Zurich, Switzerland2 days ago
SeniorFull TimeEN
We are looking for a strategic and collaborative Regional Regulatory Lead (RRL) to join our Global Regulatory Affairs team.
In this role, you will lead both strategic and operational regulatory activities within an assigned Therapeutic Area (TA) across APAC, LATAM, and Partner Business Regions. You will work closely with global and regional stakeholders to ensure timely regulatory approvals and successful lifecycle management for designated products.
Partnering with the Therapeutic Area Lead and the Global Regulatory Lead, you will contribute to global regulatory strategies while adapting and executing regional strategies aligned with business and commercial priorities.
This is an exciting opportunity to play a key role in bringing critical therapies to patients across dynamic and fast-growing international markets.
Act as the regional regulatory lead for assigned products and countries, ensuring alignment with global regulatory strategy and priorities.
Develop and implement regional regulatory strategies that support product registrations, lifecycle management, and business objectives.
Identify efficient regulatory approval pathways in collaboration with Local Regulatory Representatives (LRRs) and Regulatory Partner Representatives (RPRs).
Contribute to Global Regulatory Affairs Strategy Team (GRAST) activities and support the development of global regulatory strategies.
Lead and oversee regulatory activities across the assigned portfolio, proactively identifying and managing regulatory risks.
Ensure high-quality regulatory submissions and responses to Health Authority questions in line with regional requirements and timelines.
Collaborate closely with internal stakeholders, LRRs, and RPRs to support timely approvals and regulatory compliance.
Build and maintain strong relationships with regional Health Authorities through effective communication and high-quality documentation.
Stay informed on international regulatory legislation, guidelines, and industry developments relevant to CSL products and activities.
Assess the impact of evolving local and regional regulations and provide regulatory risk assessments.
Support continuous improvement initiatives to enhance regulatory processes, compliance, and operational excellence.
Degree in Biological Sciences, Medical Sciences, Pharmacy, or a related field.
Postgraduate qualifications or specialization in Drug Regulatory Affairs are considered an advantage.
Minimum 5 years of regulatory affairs experience within international markets.
Additional pharmaceutical or biotech industry experience is highly desirable.
Fluent English is required.
Additional languages are considered an asset (e.g., Arabic, French, Spanish, Russian).
Strong understanding of pharmaceutical product development and regulatory requirements.
Knowledge of GMP and GCP principles.
Excellent communication, stakeholder management, and organizational skills.
Ability to work effectively in a global and cross-functional environment.
This is a unique opportunity to contribute to the delivery of life-changing therapies to patients worldwide while working within a collaborative and innovative global environment.
At CSL, we are committed to continuous improvement, scientific excellence, and making a meaningful difference in patients’ lives.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our 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.
