Manager, Global Regulatory Affairs, Apac Region

At CSL Behring, we're looking for a Manager, Global Regulatory Affairs, APAC Region. You will be responsible for regional regulatory strategic and operational tasks for a range of development and registered products in the Asia Pacific (APAC) Region. 

The role

• Develop regional strategies and contribute to Global Regulatory strategies and plans for allocated product portfolio.
• Submit, in a timely and efficient manner, high quality regulatory applications for development products and variations for registered products to obtain Health Authority (HA) approval along with license renewals.
• Lead the preparation and contribute to briefing packages for HA meetings and responses to questions.
• Be the subject matter expert on regional regulatory procedures and HA requirements. Provide regulatory guidance to less experienced team members.
• Ensure compliance with the regulatory requirements for product approval and license maintenance.
• Develop relationships with regional HAs demonstrated by high-quality communication and effective negotiation skills to achieve positive outcomes for CSL Behring.
• Collaborate with internal stakeholders by providing strategic regulatory input into Commercial plans, effective communication and on-time execution of regulatory activities.

Your experience

• A degree in Biological or Medical Science or Pharmacy and/or a 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.
• Demonstrated working knowledge of regulatory guidelines and legislative requirements for Australia/New Zealand and other APAC markets.
• 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 ability, complemented by a “hands-on” operational approach and business planning orientation.
• Fluency in English; other language(s) relevant to key APAC market(s) is advantageous.

How to Apply

Please submit your applications with your current CV and covering letter.

Applications close 28 February 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.