Associate Director, Regulatory Regional Lead Au/Nz
vor 2 Monaten
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 licensed 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 licensed products and new license 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 license and new indications applications, change applications, PSUR submissions, submissions of other documents required to fulfill regulatory post-approval commitments, and briefing books required for HA meetings in the region.Be a 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 meets the content and format requirements for the regional regulatory authorities and is submitted according to agreed schedules.Provide input to budgets, 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.
A degree in Drug Regulatory Affairs is advantageous.At minimum 5 years' experience in the pharmaceutical industry, preferably in Biologics in the areas of R&D, quality, manufacturing, and 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 10 November 2024.
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