Medicine Registration Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs Associate Job Description

As a Regulatory Affairs Associate, you will play a key role in ensuring the continuity of supply via life cycle maintenance activities for our existing portfolio and supporting the registration of new medicines in Australia.

  • Key Responsibilities:
  • Deliver regulatory submissions within required timeframes;
  • Ensure accuracy and currency of company databases and systems by drafting, updating, reviewing and verifying entries;
  • Maintain compliance with relevant regulations and codes and provide regulatory advice to personnel as required;
  • Maintain up-to-date training with internal policies, standard operating procedures, and work instructions;
  • Complete allocated special projects;
  • Collaborate cross-functionally to support submissions and projects where required;
  • Support regulatory administrative activities as needed;
  • Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives.
Requirements

To be successful in this role, you should have:

  • A bachelor's degree or equivalent in Pharmacy, Science or Chemistry;
  • At least two years' experience in regulatory affairs ideally with prescription medicines;
  • Understanding of local and international regulatory guidelines;
  • Capacity to investigate and evaluate problems to develop effective solutions;
  • Excellent communication skills (written and verbal);
  • Ability to multitask and work to deadlines;
  • Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframes;
  • Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder).

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