Encore Group is inviting applications for the position of Executive – Regulatory Affairs at its Head Office located in Fort-CSMT, Mumbai. Candidates with B.Pharm or M.Pharm qualifications and 3 years of experience in ROW market dossier preparation are encouraged to apply.
This Regulatory Affairs job in Mumbai is an excellent opportunity for pharma professionals experienced in ACTD, CTD, and eCTD dossier submissions, regulatory compliance, artwork review, and international market registrations. The company offers a professional 5-day working environment with Saturday and Sunday off.
Author: pharmabharat editorial team
Job Highlights
| Particulars | Details |
|---|---|
| Position | Executive – Regulatory Affairs |
| Department | Regulatory Affairs |
| Qualification | B.Pharm / M.Pharm |
| Experience | 3 Years |
| Location | Fort – CSMT, Mumbai |
| Working Days | 5 Days Working |
| Weekly Off | Saturday & Sunday |
| Market Exposure | ROW Market |
| Employment Type | Full-Time |
About the Company
Encore Group Official Website is a reputed pharmaceutical organization engaged in regulated and semi-regulated markets with strong expertise in formulation development, manufacturing, and global regulatory compliance.
The company is expanding its Regulatory Affairs team and seeking skilled professionals experienced in dossier preparation and international submissions for ROW markets.
Key Responsibilities
The selected candidate will be responsible for:
- Preparation of ACTD, CTD, and eCTD dossiers for ROW markets
- Ensuring timely and error-free dossier submissions as per marketing timelines
- Evaluating and responding to regulatory authority queries and customer requirements
- Reviewing technical documents including:
- Process Validation
- AMV
- Stability Data
- CDP documents
- Coordinating with QA, R&D, ADL, HO, and manufacturing plants for regulatory documentation and sample requirements
- Artwork development and artwork checking for regulatory compliance
- Maintaining registration records and updating dossier status regularly
- Supporting commercial registration activities for international markets
Required Qualifications
Candidates applying for this pharma regulatory affairs job should have:
- B.Pharm or M.Pharm qualification
- Minimum 3 years of experience in Regulatory Affairs
- Hands-on exposure to ROW market dossiers
- Strong understanding of:
- ACTD
- CTD
- eCTD submissions
- Regulatory documentation
- Good communication and coordination skills
- Experience in artwork compliance and technical document review
Preferred Skills
- Knowledge of international regulatory guidelines
- Strong documentation management abilities
- Coordination with cross-functional teams
- Attention to detail in dossier compilation
- Ability to handle multiple submissions simultaneously
Salary Details
Based on industry standards for Regulatory Affairs Executive jobs in Mumbai, the expected salary range is:
- ₹4.8 LPA – ₹7.5 LPA
Salary may vary depending on candidate experience, dossier handling expertise, and regulatory market exposure.
Benefits
- 5 Days Working
- Weekend Off (Saturday & Sunday)
- Career growth in global regulatory affairs
- Exposure to ROW market submissions
- Professional work environment
- Opportunity to work with cross-functional pharma teams
How to Apply
Interested candidates can send their updated resume to:
Contact Person: Rashmi Parab – Manager Group HR
📧 Email: rparab@encoregroup.net