Executive- DRA

Sava Healthcare

2 - 7 years

3 - 4 Lacs

pune

Posted:4 hours ago| Platform:

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Skills Required

europe regulatory affairs ra

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Preparation of regulatory dossiers in
eCTD format for Europe
(hands-on experience in eCTD is a must).
Thorough understanding and working knowledge of
EU regulatory procedures
including DCP (Decentralized Procedure) and MRP (Mutual Recognition Procedure).
Compilation and submission of regulatory dossiers for
ROW (Rest of the World) markets
.
Coordination and preparation of responses to
deficiencies/queries
received from Regulatory Agencies.
Application of
ICH and EU regulatory guidelines
during dossier preparation and submission.
Preparation and submission of
variation packages for approved products
in compliance with applicable regulations.

Desired Profile:

Bachelors/Master’s degree in Pharmacy or Life Sciences.
2–5 years of relevant experience
in Regulatory Affairs with proven expertise in eCTD dossier preparation.
Good knowledge of
EU regulatory environment
and ROW regulatory requirements.
Strong analytical, documentation, and communication skills.
Ability to work independently as well as in cross-functional teams.

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