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Associate Director, Regulatory Regional Lead Au/nz
3 months ago
We have an opportunity available for an Associate Director, Regulatory APAC Region Lead to join our team. You will be a team leader responsible for executing all regional regulatory strategic and operational tasks for licenced products and development projects/products in the region.
You will establish and maintain working relationships with the respective regional Regulatory Agencies and other external stakeholders.
Reporting to the APAC TA Lead, you will:
- Act as the Subject Matter Expert on regional, regulatory procedures and HA requirements and primary regional contact for strategic oversight on the allocated TA for the Region
- Ensure that documentation for submissions in the region meet the content and format requirements for the regional regulatory authorities and is submitted according to agreed schedules.
- Provide input to budgets, to resource plans and monitor activities and progress to ensure strategic goals for the CSL Behring products in the region are achieved.
Your Experience:
- A degree in Biological or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous.
- At minimum 5 years’ experience in the pharmaceutical industry, preferably in Biologics in the areas R&D, quality, manufacturing, Regulatory Affairs.
- At least 5 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.
- Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities.
Applications close on 2 June 2024
**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**:
