We are looking for a Regulatory Affairs Officer / Associate Consultant to join the team in India.

The successful candidate will support regulatory activities for Australia, New Zealand, and the JAPAC region, including dossier preparation, eCTD publishing, lifecycle maintenance, and submissions to the TGA and Medsafe.

Key responsibilities

- Support the registration and listing of pharmaceuticals, biologicals, and medical devices.
- Support lifecycle maintenance of existing registrations and listings.
- Provide eCTD publishing support.
- Review, critically evaluate, prepare, and submit regulatory dossiers to the TGA and Medsafe.
- Assist clients with responses to questions from regulatory authorities.
- Support senior team members with complex regulatory applications.
- Assist with project and client-management activities.
- Prepare and manage GMP clearance applications.
- Prepare, review,



and update quality documentation.

Requirements

- Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.
- Minimum three years of regulatory affairs experience.
- Experience with Australian and Current Zealand regulatory activities in a commercial environment is preferred.
- Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures.
- Strong attention to detail and ability to meet deadlines.
- Good problem-solving and project-management skills.
- Excellent written and verbal communication skills.
- Ability to handle confidential information.
- Interest in consulting and willingness to learn and develop.
- Fluent English.

📌 Regulatory Affairs Officer / Associate Consultant (India)
🏢 ProductLife Group
📍 India