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In this role, you will prepare and execute regulatory submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas, covering both Australia and New Zealand.
This role requires strong attention to detail, excellent communication skills, and a deep understanding of regulatory guidelines and processes within the pharmaceutical industry.
• Prepare and submit regulatory dossiers to health authorities for new product approvals and maintenance variations.
• Ensure compliance with all relevant regulations, guidelines, and company policies.
• Monitor and analyse regulatory changes and trends to ensure company compliance.
• Assist in the development and implementation of regulatory strategies for new and existing products.
• Maintain up-to-date knowledge of global regulatory requirements and ensure that company practices align with these standards.
• Review and approve labelling, promotional materials, and other product-related documentation for regulatory compliance.
• Bachelor’s degree in Life Sciences, Pharmacy, Biological sciences, or nursing.
• Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry with hands on experience with NCE and complex generic submissions.
• Experience preparing category 1 applications.
• Proven track record of successful regulatory submissions and product approvals.
• Working relationships with the TGA and/or Medsafe and other relevant government agencies.
• Strong communication and interpersonal skills.
• Strong attention to detail, resilience, and an ability to bring innovative ideas to problem solving.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Generous leave, health, and wellbeing benefits.
• Commitment to ongoing personal & professional growth via a blend of learning opportunities.
• Opportunity to join a leading global organisation with a network of 37,000 employees operating in 60 markets, with 25 R&D sites.
Regulatory Affairs Manager ANZ
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