Regulatory Affairs Executive

AMBIX HEALTHCARE LLP; Mumbai; On-site; INR 350,000 - 550,000; Full time

Job summary

AMBIX HEALTHCARE LLP in Mumbai is seeking a Regulatory Affairs Executive with 1–2 years of experience to join our regulatory team. You will prepare CTD/ACTD dossiers and country submissions for ROW markets and collaborate with QA, QC, Production, and Development.

The role requires attention to detail, timely submissions, and staying updated with ICH, CDSCO, WHO, FDA, EMA, MOH guidelines. You will coordinate with Licensing for COPP, FSC, and maintain regulatory trackers.

Qualifications

• Background in Pharmacy or Life Sciences.
• 1–2 years of experience in regulatory affairs or related field.
• Eager to grow in the global regulatory domain.

Responsibilities

• Prepare CTD/ACTD dossiers and country submissions for ROW markets (Africa, MENA, LATAM, CIS, Asia).
• Handle authority queries and ensure timely submission of responses.
• Review packaging artworks and coordinate final approvals.
• Collect & compile regulatory data (Q&Q, COAs, COPPs, stability, FPS/FPMOA, procedures).
• Coordinate with QA, QC, Production, Packaging & Development teams.
• Arrange product samples and standards for registrations/renewals.
• Coordinate with Licensing for COPP, FSC, and administrative documents.
• Maintain regulatory trackers and ensure documentation compliance.
• Support in audits, GMP documentation & client/authority queries.
• Stay updated with ICH/CDSCO/WHO/FDA/EMA/MOH guidelines.
• Knowledge of CTD/ACTD formats.
• Attention to detail and ability to meet timelines.
• Positive attitude, analytical mindset & teamwork abilities.

Skills

Regulatory affairs

CTD/ACTD

Documentation

Attention to detail

Timelines management

Teamwork

Education

Pharmacy

Life Sciences

Job description

We Are Hiring – Regulatory Affairs Executive (1–2Years)

Department: Regulatory Affairs

We are looking for a motivated and detail-oriented Regulatory Affairs Executive to join our team. If you have a background in Pharmacy or Life Sciences and are eager to grow in the global regulatory domain, this opportunity is for you!

Key Responsibilities

Prepare CTD/ACTD dossiers and country-specific submissions for ROW markets (Africa, MENA, LATAM, CIS, Asia)

• Handle authority queries and ensure timely submission of responses
• Review packaging artworks and coordinate final approvals
• Collect & compile regulatory data (Q&Q, COAs, COPPs, stability, FPS/FPMOA, procedures)
• Coordinate with QA, QC, Production, Packaging & Development teams
• Arrange product samples and standards for registrations/renewals
• Coordinate with Licensing for COPP, FSC, and administrative documents
• Maintain regulatory trackers and ensure documentation compliance
• Support in audits, GMP documentation & client/authority queries
• Stay updated with ICH/CDSCO/WHO/FDA/EMA/MOH guidelines
• Knowledge of CTD/ACTD formats
• Attention to detail and ability to meet timelines
• Positive attitude, analytical mindset & teamwork abilities