Role & responsibilities: (Australia, UK, USA)

Job Purpose To manage regulatory submissions, product registrations, and lifecycle activities for pharmaceutical products in Australia, the UK, and the USA, ensuring compliance with applicable regulatory requirements and timely achievement of registration and approval targets.

Key Responsibilities

- Prepare, compile, review, and submit CTD/eCTD dossiers for new marketing authorisation applications and generic product registrations.
- Manage regulatory submissions to TGA (Australia), MHRA (UK), and US FDA, including new applications, variations, renewals, amendments, supplements, and other post-approval changes.
- Manage applicable US regulatory pathways, including ANDAs and relevant post-approval submissions.
- Prepare and coordinate responses to health authority queries, deficiency letters, information requests, and assessment reports.
- Review CMC documentation, pharmaceutical development data, bioequivalence studies, stability data, specifications, and manufacturing information.
- Manage product information updates, including SmPC, PIL, labelling, and packaging changes,



as applicable to the UK and Australia.
- Coordinate with cross-functional teams, including Quality Assurance, Quality Control, Formulation Development, Analytical Development, Clinical, and Pharmacovigilance, as well as CMOs and external regulatory consultants.
- Monitor regulatory guidelines and updates from TGA, MHRA, and US FDA, assessing their impact on ongoing and approved products.
- Maintain regulatory trackers, submission timelines, approval records, and regulatory commitments.

Preferred candidate profile

- Minimum 7 years of pharmaceutical Regulatory Affairs experience, with hands-on exposure to Australia, UK, and/or US regulatory submissions.
- Solid knowledge of CTD/eCTD dossier preparation, generic drug registrations, and regulatory lifecycle management.
- Working knowledge of TGA registration requirements, MHRA marketing authorisation procedures, and US FDA submission pathways.
- Ability to manage multiple products, submissions, and regulatory deadlines independently.

📌 Assistant Manager - Regulatory Affairs (UK, USA & Australia) (Vadodara)
🏢 Novumgen
📍 Vadodara