Assistant Manager - Regulatory Affairs (UK, USA & Australia)

Novumgen; Vadodara; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Novumgen Limited in Vadodara, Gujarat, seeks an experienced Regulatory Affairs professional to manage submissions for Australia, UK and USA, ensuring compliance and timely approvals.

You will prepare CTD/eCTD dossiers, coordinate global submissions, review CMC data, and collaborate with QA, Manufacturing, Clinical, and external consultants to maintain lifecycle activities.

7+ years experience required; familiarity with TGA, MHRA, and US FDA preferred.

Qualifications

• Minimum 7 years of pharmaceutical Regulatory Affairs experience with exposure to Australia, UK and/or US submissions.
• Strong knowledge of CTD/eCTD dossier preparation and regulatory lifecycle management.
• Experience with TGA, MHRA and US FDA submission pathways.

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.

Skills

CTD/eCTD dossiers

Regulatory submissions

Lifecycle management

TGA/MHRA/US FDA knowledge

Project coordination

Job description

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.
• Strong 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.