Regulatory Affairs Executive - Fort ( Mumbai )

Encore Healthcare; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Encore Healthcare in Mumbai is seeking an experienced Regulatory Affairs professional to manage dossier preparation for the ROW market. You will coordinate with HO, Plant and R&D to gather documents and ensure submission readiness according to CTD/ACTD/ECTD formats.

You will respond to regulatory queries, file post-approval variations, and review technical documents to ensure compliance with dossier requirements and timelines. Strong documentation control and communication skills are essential.

Qualifications

• 3+ years of experience in dossier preparation for ROW market.
• Experience in CTD/ACTD/ECTD formats and regulatory submissions.
• Knowledge of variation filings and health authority interactions.

Responsibilities

• Prepare CTD/ACTD/ECTD dossiers and country specific formats for ROW market, on schedule.
• Evaluate and respond to regulatory queries from health authorities or customers.
• File post-approval variations with regulatory agencies per guidelines.
• Review process validation, AMV, Stability, PDR, CDP against dossier requirements.
• Coordinate with HO/Plant/R&D for documents and samples for dossier/registration.

Skills

Dossier preparation

Regulatory affairs

Document control

Communication

Education

B. Pharma / M. Pharm

Job description

Role & responsibilities

• 1. Dossier Preparation CTD/ACTD/ ECTD and Country Specific format for ROW market & to ensure error free & timely submissions as per provided timelines.
• 2. To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
• 3. To file post approval variations to regulatory agencies for registered products as per variation guidelines.
• 4. To review technical documents like process validation, AMV, Stability, PDR and CDP etc. received from Site QA or R&D against Dossier requirements.
• 5. To Coordinate with respective dept. in HO /Plant / R&D for documents & samples required for dossier / registration purpose.
• 5. Development of New Artworks and Checking for registration and commercial purpose as per regulatory requirement.

Preferred candidate profile .

6. To Maintain & Update regulatory database for all Manufacturing, Quality documentation, Dossier files and RLD samples.

7. Application and checking of admin documents like product permission, COPPS, FSCs.

Location Head Office, Fort - CSMT

Department - Regulatory Affairs

Education - B. Pharma / M. Pharm

Experience – 3 Years + ( Must have working experience of Dossier preparation for ROW Market )

Working – 5 Days Working

Weekly Off – Saturday Sunday