Regulatory Affairs Professional

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $105,000
Job Description

We are seeking a highly skilled Regulatory Affairs Professional to join our team. As a key member of our organization, you will play a crucial role in ensuring the continuity of supply via lifecycle maintenance activities for our existing portfolio and supporting the registration of new medicines in Australia.

Compliance with local and global regulations is essential in the ever-changing regulatory environment. You will be responsible for delivering regulatory submissions within required timeframes, ensuring company databases and systems are accurate and current, and maintaining compliance with relevant regulations and codes.

You will also provide regulatory advice to company personnel as required, maintain compliance and up-to-date training with internal Policies, Standard Operating Procedures, and Work Instructions, and adhere to company values and expectations.

Required Skills and Qualifications
  • 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 a problem 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).
Benefits

This role offers a challenging and rewarding career path, with opportunities for professional growth and development. You will have the opportunity to work on a variety of projects, including regulatory submissions, product launches, and post-marketing surveillance.

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