Local Regulatory Representative Lead
Entity: CSL Behring
Job Category: Research Development & Sciences
Job Family: Global & Regional Regulatory Affairs
Job Type: Full Time
Location: Singapore, Singapore
Employer Reference: R-294278
Job Description
Job Overview
Welcome to CSL, where science meets purpose and every day brings a chance to help patients around the world. We are looking for a Regulatory Representative Lead to bring strategic, forward-thinking regulatory leadership to our APAC Region. In this role, you will guide affiliate and distributor regulatory management and shape regional regulatory strategies for new and existing CSL Behring products. Your work will span every developmental and commercial lifecycle phase across multiple markets.
Responsibilities
You will be part of a team of high-performing regulatory affairs professionals who work together in a productive, harmonized way to bring CSL Behring commercial plans to life in APAC. You will:
- Build and nurture this team, supporting each member to thrive.
- Collaborate closely with regional regulatory experts in the Therapeutic Areas across APAC markets.
- Design, deploy and maintain processes and systems that help distributors meet CSL, global and local regulatory compliance, including on-boarding, training and off-boarding.
- Provide strategic leadership, including risk-based oversight of regional programs. You will draw on stakeholder management and business planning knowledge to optimize implementation plans.
- Plan, lead and deliver complex regional strategies across a broad range of CSL Behring and CSL Vifor products and markets, keeping them aligned with company and commercial strategies.
- Take on other duties that may be assigned from time to time.
Requirements
- An advanced degree in natural or related life sciences (MS, PhD or MD, DVM).
- 7 – 10 years of relevant experience in the pharmaceutical industry; biologics regulatory experience preferred.
- Demonstrated experience of strategic leadership across product development and commercialisation lifecycle with examples of contribution.
- Demonstrated experience in building high performing RA teams and effective delivery of objectives in a complex matrix environment.
About CSL Behring
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.