Emcure Pharmaceuticals has announced an opening for a DRA Officer – EU Market in Ahmedabad. This opportunity is suitable for M.Pharm professionals with 1–5 years of experience in Drug Regulatory Affairs, particularly those who have worked with European Union (EU) and UK regulatory markets.
The position focuses on regulatory dossier authoring, Modules 1–5, post-approval variations, health authority query responses, eCTD documentation and compliance with ICH guidelines. Candidates with exposure to initial Marketing Authorisation Applications will have an additional advantage.
For regulatory affairs professionals looking to strengthen their careers in EU regulatory affairs and international pharmaceutical registrations, this Emcure DRA Officer vacancy offers relevant hands-on exposure.
Emcure DRA Officer Job Overview
| Particulars | Details |
|---|---|
| Company | Emcure Pharmaceuticals |
| Position | DRA Officer – EU Market |
| Department | Drug Regulatory Affairs |
| Industry | Pharmaceutical & Life Sciences |
| Location | Ahmedabad |
| Employment | Full-Time, Permanent |
| Experience | 1–5 Years |
| Qualification | M.Pharm in Any Specialization |
| Regulatory Markets | EU and UK |
| Openings | 1 |
| Salary | Not disclosed by employer |
Key Responsibilities
As a DRA Officer for the EU Market at Emcure, the selected candidate will support regulatory activities associated with pharmaceutical submissions and lifecycle management.
Key responsibilities include:
- Support the authoring of regulatory documentation across Modules 1–5.
- Compile and review documents required for regulatory submissions.
- Work on regulatory activities for EU and UK markets.
- Handle or support post-approval variation activities.
- Assist with responses to queries raised by health authorities.
- Maintain regulatory documentation in accordance with eCTD requirements.
- Ensure submissions and documentation comply with applicable ICH guidelines.
- Review regulatory documents for completeness, consistency and submission readiness.
- Support initial Marketing Authorisation Application activities where required.
- Coordinate documentation needed for ongoing regulatory lifecycle activities.
Qualification & Eligibility
Candidates interested in the Emcure DRA Officer EU Market job should meet the following requirements:
Educational Qualification:
M.Pharm in any specialization.
Experience Required:
The job listing specifies 1–5 years of experience.
Candidates should have relevant regulatory market experience involving EU and UK countries. Previous experience supporting or authoring Modules 1–5 is important for this position.
Experience with post-approval variations is also required, while exposure to initial Marketing Authorisation Applications is considered an added advantage.
Key Skills Required
Applicants should have working knowledge or experience in:
- Drug Regulatory Affairs (DRA)
- EU Regulatory Affairs
- UK Regulatory Market
- eCTD
- ICH Guidelines
- Regulatory Dossier Compilation
- Modules 1–5
- Post-Approval Variations
- Marketing Authorisation Applications
- Health Authority Queries
- Regulatory Document Review
- Pharmaceutical Regulatory Submissions
Candidates who have already worked on European pharmaceutical regulatory submissions may be particularly aligned with the responsibilities described in the vacancy.
Why Consider This Opportunity?
The Emcure DRA Officer EU Market recruitment can be relevant for regulatory affairs professionals seeking greater exposure to international markets.
The role provides opportunities to work with EU and UK regulatory requirements, dossier documentation, post-approval lifecycle activities, eCTD submissions and health authority queries.
Professionals building a long-term career in areas such as EU regulatory affairs, global regulatory affairs, regulatory operations and pharmaceutical lifecycle management may find this experience valuable.
Who Should Apply?
This vacancy may be suitable for:
- M.Pharm professionals with 1–5 years of regulatory affairs experience.
- Regulatory Affairs Officers or Executives working with EU/UK markets.
- Candidates experienced in eCTD dossier preparation and compilation.
- Professionals with hands-on experience in Modules 1–5.
- Candidates experienced with post-approval variations.
- Regulatory professionals familiar with ICH guidelines and health authority responses.
Important: This is not advertised as a fresher position. The employer has specifically listed 1–5 years of experience and expects relevant EU/UK regulatory market exposure.
How to Apply
