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.
Qualifications
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.
