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Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive

Red Envelope Consultants

6 - 11 years

6 - 8 Lacs

ahmedabad

Posted:None| Platform:

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Skills Required

regulatory affairs latam drug regulatory affairs ctd dossier preparation row market dossier actd regulatory documentation latin america

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Key Responsibilities:

Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations.
Coordinate with agents/distributors for submissions and query responses.
Track timelines and ensure compliance with regulatory guidelines (LATAM, Africa, CIS, Asia).
Manage product lifecycle: variations, renewals, packaging/labelling updates.
Maintain regulatory databases and trackers.

Key Skills:

Strong knowledge of RoW regulatory requirements & dossier formats.
Experience with LATAM countries (Brazil, Mexico, Argentina, Chile, etc.).
Excellent documentation, coordination & communication skills.
Proficiency in MS Office & regulatory databases.

Other Details:

Will lead a team of 4 RAs and report to Director.
Immediate joiners preferred (short notice period).

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