Associate Director, Regulatory Regional Lead AU/NZ
vor 1 Monat
Pharmaceuticals & Medical Devices (Healthcare & Medical)
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 provide regional regulatory input into global regulatory teams and plans and ensure that the Regional Regulatory Therapeutic Area Team supports the Global Regulatory Affairs (GRA) vision of excellence, regarding the maintenance of licenced products and new licence applications and development projects in the allocated TA, through solid regulatory strategies, good scientific practice, integrity and compliance with regulatory standards.
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:
- Be responsible for regulatory procedures like new licence and new indications applications, change applications, PSUR submissions, submissions of other documents required to fulfil regulatory post approval commitments and of briefing books required for HA meetings in the region.
- 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.
Apply now to join Australia’s leading biopharmaceutical company, committed to protecting public health
Applications close on 2 June 2024
We encourage you to make your well-being a priority. It’s important and so are you.
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.
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
It began with a promise. CSL, was formed more than 100 years ago to save lives using the latest technologies. In the century since, CSL has grown into a global biotechnology leader, driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. Our ability to innovate and deliver life-saving medicines for patients with rare disease and other unmet medical needs around the world has earned us a reputation for always putting patients first. We are CSL and we are driven by our promise.
It began with a promise. CSL, was formed more than 100 years ago to save lives using the latest technologies. In the century since, CSL has grown into a global biotechnology leader, driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. Our ability to innovate and deliver life-saving medicines for patients with rare disease and other unmet medical needs around the world has earned us a reputation for always putting patients first. We are CSL and we are driven by our promise.
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