Regulatory Affairs Officer Jobs at Emcure Pharmaceuticals in Ahmedabad for experienced candidates with CTD eCTD expertise in global submissions and emerging markets exposure.
Introduction
Emcure Pharmaceuticals is currently seeking experienced professionals for Regulatory Affairs roles at its Ahmedabad location. This opportunity is well-suited for candidates with hands-on experience in dossier preparation and global regulatory submissions. If you are looking to work on international markets and strengthen your expertise in regulatory affairs, this role offers a strong platform for career advancement.
Company Overview
Emcure Pharmaceuticals is one of India’s leading pharmaceutical companies with a strong presence in domestic and international markets. The organization is known for its high-quality formulations, robust research capabilities, and compliance with global regulatory standards. With operations across multiple countries, Emcure continues to expand its footprint in emerging markets through innovation and regulatory excellence.
Job Overview
| Job Title | Officer – Regulatory Affairs (Emerging Markets) |
|---|---|
| Company Name | Emcure Pharmaceuticals |
| Location | Ahmedabad, Gujarat |
| Employment Type | Full-Time |
| Qualification | B.Pharm / M.Pharm |
| Experience | 3–8 Years |
| Salary | ₹6 LPA – ₹12 LPA (Estimated) |
| Application Mode |
Job Location & Employment Type
This is a full-time, on-site position based in Ahmedabad, Gujarat. The selected candidate will work closely with cross-functional teams to manage regulatory submissions and compliance for global markets.
Open Positions / Department Details
Emcure Pharmaceuticals is hiring for:
- Regulatory Affairs – Emerging Markets
This role focuses on handling regulatory submissions and lifecycle management for international markets including Africa, LATAM, CIS, MENA, and Asia.
Key Roles & Responsibilities
- Prepare, review, and submit CTD and eCTD dossiers for various international markets
- Manage product registrations, re-registrations, and variations
- Handle regulatory queries and ensure timely responses
- Perform gap analysis for new product submissions
- Develop regulatory strategies for emerging markets
- Review technical documents, labeling, and artwork for compliance
- Coordinate with internal teams such as R&D, QA, and production for documentation
- Ensure adherence to global regulatory guidelines and country-specific requirements
- Maintain lifecycle management activities for registered products
Eligibility Criteria
Education:
- B.Pharm
- M.Pharm
Experience:
- Minimum 3 years and up to 8 years of experience in Regulatory Affairs
- Experience in handling emerging markets is preferred
Skills Required:
Technical Skills:
- Strong knowledge of CTD and eCTD dossier preparation
- Experience in international regulatory submissions
- Understanding of lifecycle management and regulatory strategy
- Familiarity with global regulatory guidelines
Soft Skills:
- Excellent communication and coordination skills
- Strong analytical and problem-solving ability
- Attention to detail
- Ability to manage multiple projects and deadlines
- Team collaboration skills
Salary & Benefits
- Estimated salary range: ₹6 LPA to ₹12 LPA based on experience
- Opportunity to work on global regulatory submissions
- Exposure to international markets including Africa, LATAM, CIS, and MENA
- Career growth in regulatory affairs domain
- Collaborative and professional work environment
Selection Process
The selection process may include:
- Resume shortlisting
- Technical interview focusing on regulatory knowledge
- HR interview for final discussion
- Offer release and onboarding
Candidates should be prepared with practical knowledge of dossier preparation and regulatory guidelines.
How to Apply
Interested candidates can apply by sending their updated CV along with current and expected CTC to:
Ensure your resume clearly highlights your regulatory experience and relevant project work.
Why Apply for This Pharma Job?
This role at Emcure Pharmaceuticals offers a significant opportunity for professionals aiming to build expertise in global regulatory affairs. Working on international submissions enhances your exposure to different regulatory frameworks and strengthens your professional profile.
The position also provides the chance to collaborate with cross-functional teams and gain insights into product lifecycle management, making it a valuable step for long-term career growth in the pharmaceutical industry.
Important Note / Disclaimer
PharmaJobHub.in is an independent job information platform. We do not provide any recruitment guarantee and are not affiliated with any company. Candidates are advised to verify details from official sources before applying.
Final Call-to-Action
Experienced candidates in regulatory affairs are encouraged to apply at the earliest to take advantage of this opportunity. Early applications can improve your chances of being shortlisted.
