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Open nowPosted 103 days ago

Executive- DRA

SAVA HEALTHCARE38 open roles

Where
Pune
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Your applicationOpen nowExecutive- DRASAVA HEALTHCARE · Pune

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on SAVA HEALTHCARE's own form.

The reply lands in your private mailbox

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 103 days ago

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.

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    The review screen in CV Rocket: how each CV was read, round by round.

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