Regulatory Affairs Professional

3 weeks ago


Tennant Creek, Australia Innomar Strategies Full time

We are seeking a highly skilled Regulatory Affairs professional to join our team at Innomar Strategies. As a key member of our regulatory team, you will play a crucial role in ensuring compliance with local Health Authority regulations, guidelines and policies.

This is an exciting opportunity for an experienced professional to leverage their knowledge of regulatory submissions, time management and multi-tasking skills, strategic planning and problem-solving skills to drive results.

Key Responsibilities:

  • Coordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects.
  • Participate in cross-functional teams to support regulatory strategies and help achieve business results.
  • Identify client and dossier issues and develop effective strategies to address them.
  • Build and maintain a positive and productive liaison with internal and external contacts.
  • Prioritize and monitor assigned projects to meet budget, timelines and client expectations.

Requirements:

  • B.Sc. (advanced degree preferred) in Life Sciences or extensive equivalent experience and related training.
  • Certification in Regulatory Affairs (RAC) and other relevant certifications an asset.
  • 5+ years Regulatory Affairs or related relevant experience within the healthcare products industry or consulting.

The successful candidate will have strong analytical and mathematical skills, effective organizational skills, attention to detail, ability to consistently meet deadlines, and demonstrated ability to work in a cross-functional, multi-disciplinary team environment.

We offer a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness, including medical, dental, and vision care, paid parental leave, and paid caregiver leave.

A competitive salary of $120,000 - $150,000 per annum, commensurate with experience, is offered for this position. If you are a motivated and detail-oriented individual looking for a challenging role in regulatory affairs, please apply.



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