Brookfield

The Opportunity

Due to an internal promotion within CSL we are looking for a Regional Regulatory Manager ANZ. Reporting to the Therapeutic Area Lead - Regulatory Affairs you will be responsible for all regional regulatory strategic and operational tasks for a range of products in the assigned Therapeutic Area. Your responsibilities will cover products under development and licensed in the ANZ Region

The Role

• Develop regional strategies, contribute to global regulatory strategies/plans.
• Submit regulatory applications for development products and change applications for registered products to obtain HA approval in the fastest way.
• Be the Subject Matter Expert on regional regulatory procedures and HA requirements. Provide regulatory expert guidance to less senior TA team members
• Ensure compliance with the regional regulatory requirements pertaining to product approval and license maintenance.
• Lead the preparation and contribute to briefing packages for HA meetings associated with established products. Support Scientists for this type of activities.
• Develop strong working relationships with regional Regulatory Agencies demonstrated by high quality to achieve positive outcomes for CSL Behring.

Your skills and experience

• A degree in Biological or Medical Science or Pharmacy,
• Post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
• At least 3+ years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
• Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product.
• Understanding of the principles of GMP, GCP and GLP.
• Strategic and tactical thinking ability, complemented by a "hands-on" operational approach and business planning orientation.

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you.

About CSL

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia 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 through innovation.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.

Do work that matters at CSL!

Our Benefits

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.

About CSL Behring

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.

We want CSL to reflect the world around us

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

Do work that matters at CSL Behring!