Regional Therapeutic Area Lead, Global Regulatory Affairs, Apac Region

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people.

We are seeking an experienced Therapeutic Area (TA) Lead APAC to join our Regulatory Affairs team. You will provide leadership, strategic direction and managerial oversight to the APAC Regulatory Affairs team.

You will define and execute regulatory strategies for CSL products and development programs in APAC region and will develop and maintain strong working relationships with Health Authorities (HAs).

Reporting to the Global Regulatory Affairs Head of Biotherapies APAC, you will:

• Lead the team in development of regional regulatory strategies for CSL’s pipeline products and execution of high quality new product regulatory applications.
• Lead the team responsible for LCM for approved products in APAC.
• Lead regulatory procedures including Health Authority meetings, clinical trial applications, marketing applications, change management applications, licence renewals, agency meetings, Periodic Safety Update Reports (PSUR), required reporting activities related to clinical or marketing applications/approvals.
• Promote collaborative relationships with internal and external stakeholders, with a focus on engagement of APAC Health Authorities.
• Build productive and collaborative partnerships with Commercial Operations and R&D.
• Provide input to budgets and resource plans; monitor activities and progress to ensure strategic objectives are achieved.
• Drive innovation and best in class approach to general regulatory operations and processes  
• Mentor junior Regulatory Affairs professionals, fostering their development within the organisation.

Your Experience:

• A degree in Biological or Medical Science or Pharmacy preferably with a post graduate qualification.
• At least 10 years of regulatory experience, supported by additional pharmaceutical/ industry experience.
• Minimum two years of people management experience.
• Experience at a senior level in Regulatory Affairs, Quality, or other relevant pharmaceutical industry roles with a knowledge of Regulatory Affairs legislation and processes (TGA, Medsafe, EMA)
• Demonstrated experience across drug development and commercialization lifecycle, with examples of contribution.
• Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities with biological products.

Apply now to join Australia’s leading biopharmaceutical company!

Applications Close on 21 April 2024

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant Therapeutic Areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.