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Regulatory Affairs Specialist
2 weeks ago
We're seeking a seasoned regulatory affairs professional to join our team as a Consultant. In this key role, you'll play a pivotal part in delivering high-quality regulatory outcomes across Australia and New Zealand.
The ideal candidate will have a strong background in regulatory affairs, preferably with experience in a commercial environment. You'll be responsible for preparing, reviewing, and submitting regulatory dossiers to authorities, ensuring compliance with regulatory frameworks and guidance.
You'll also serve as the regulatory project coordinator for assigned submissions, tracking deliverables, timelines, and risk mitigation plans. Additionally, you'll liaise with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
About the Role- Key Responsibilities:
- Prepare, review, and submit regulatory dossiers to authorities.
- Ensure compliance with regulatory frameworks and guidance.
- Serve as the regulatory project coordinator for assigned submissions.
- Liaise with medical, safety, quality, and supply chain teams.
- Bachelor's degree in science, pharmacy, or a related discipline.
- Minimum 5 years' experience in regulatory affairs.
- Experience in reviewing, critically evaluating, and presenting clinical data.
- Good knowledge of legislation, regulations, guidelines, and working procedures within Australia, New Zealand, and the JAPAC region.
- High-level written and oral communication skills.
- Proven problem-solving and project management skills.
- Reasonable computer literacy.
- Ability to deal with high levels of confidentiality.
- Previous experience in project management and/or consulting.
