hirly
Sign inGet started free

SAVA HEALTHCARE

Executive- DRA

Pune, India

See how you match this job — and similar ones. Free.

Upload your resume and hirly scores it against this role at SAVA HEALTHCARE first, then against similar open jobs, and shows where you fit and why.

PDF or DOCX, up to 12MB. No sign-up to see your matches.

Get past the screening software and onto a recruiter's desk

hirly rewrites your resume for this job — matching the keywords and skills in the posting, moving your most relevant experience to the top, and writing a cover letter to fit. About 30 seconds.

  • Keywords matched to this posting
  • Fit score before you apply
  • Cover letter included

Matched against 2.5M live jobs from 200,000+ employers in 200+ countries.

Tailor my resume for this job →

Apply from your AI assistant

Connect hirly to Claude and ask it to apply to this job. hirly tailors your resume, fills the employer’s form and asks before sending. ChatGPT: manual setup today.

See how it works

Some employer sites stop an application at a CAPTCHA or sign-in and hand it back with a link. Applying needs a paid plan. Works with any assistant that supports MCP.

hirly's read of this role

Seniority
Mid level
Country
IN
Work mode
On-site / unstated
First seen by hirly
23 Sept 2026

Derived automatically from the posting. Upload your resume above to see how the role scores against it.

the posting

Job Purpose

To support the Regulatory Affairs function by preparing, compiling, and submitting dossiers for ROW (Rest of World) and EU markets , handling variations, and managing renewals in compliance with applicable regulatory guidelines.

Key Responsibilities

1. Dossier Preparation (ROW & EU)

Preparation and compilation of CTD/eCTD dossiers for ROW and EU markets.

Review and verification of technical documents (Module 1–5).

Coordination with QA, QC, Production, R&D, and other departments for required documentation.

Ensuring submissions comply with guidelines of regulatory authorities such as European Medicines Agency and respective country regulations.

Handling deficiency queries and preparing responses within stipulated timelines.

2. Variation Management

Preparation and submission of variation dossiers (Type IA, IB, Type II as applicable).

Tracking variation approvals and implementation timelines.

Maintaining updated records of approved variations.

3. Renewals

Preparation and submission of renewal dossiers within regulatory timelines.

Coordination for updated documents required for renewals.

Tracking renewal status and maintaining regulatory database.

4. Regulatory Compliance & Documentation

Maintaining regulatory trackers and submission databases.

Ensuring document archival as per SOPs.

Supporting audits and inspections related to regulatory documentation.

Educational Qualification

B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)

Experience

2–5 years of experience in Regulatory Affairs.

Hands-on experience in ROW and EU dossier preparation.

Experience in handling variations and renewals.

Key Skills & Competencies

Strong knowledge of CTD/eCTD format.

Understanding of EU and ROW regulatory guidelines.

Good documentation and coordination skills.

Attention to detail and timeline management.

Proficiency in MS Office and regulatory software tools.

Original posting on SAVA HEALTHCARE's site ↗

Browse similar roles

Want this one?

Upload your resume and hirly rewrites it for this job and writes the cover letter — in about thirty seconds, before you sign up.

Tailor my resume for this job