Regulatory Affairs Consultant – Remote

About the role

We have a collaborative, results-driven and high-performance team culture, balanced with a trusting amount of individual autonomy and flexibility.

Reporting to the Chief Medical Officer, the Regulatory Consultant will be responsible for advising and supporting the Company through the complex process of IND and FDA submissions, providing strategic regulatory guidance, and ensuring that all submissions meet regulatory requirements.

Responsibilities:

• IND & FDA Submissions: Prepare, review, and submit IND applications and FDA submissions for clinical trials and research projects, ensuring accuracy, completeness, and compliance with regulatory requirements.
• Regulatory Strategy: Develop and implement regulatory strategies to facilitate the efficient approval of clinical trials and research projects in collaboration with clients and internal teams.
• Regulatory Compliance: Stay up-to-date with relevant Australian and FDA regulations, guidelines, and best practices, and ensure that all activities are conducted in accordance with these regulations.

Skills & Experience:

• Bachelor’s degree in Pharmaceutical/Biomedical Sciences or related fields.
• Proven experience with IND submissions and FDA regulatory processes.
• Strong knowledge of Australian regulatory requirements and FDA regulations, with specific domain knowledge in FDA 21 CFR regulations.
• Excellent written and verbal communication skills.
• Attention to detail and ability to work in a highly regulated environment.
• Strong problem-solving and analytical skills.
• Ability to work independently and collaboratively in a team.