Officer/Executive - RA

Quality HR Services

2 - 5 years

3 - 6 Lacs

vapi

Posted:10 hours ago| Platform:

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Skills Required

regulatory writing ectd ctd dossier compilation document management actd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions.
Handle full lifecycle of product registration including new submissions, renewals.
Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc.
Address Ministry of Health (MoH) queries and manage deficiency responses.
Manage post-approval changes and variation submissions.
Liaise with international regulatory agents and distributors for submission coordination.
Artwork review and approval ensuring compliance with label regulations.
Maintain up-to-date registration database and submission tracker.
Prepare administrative documents: POAs, LOAs, legalization support, etc.
Conduct compliance review for change controls, tech transfer documents, and CMO
Support site registration and GMP audits when required.
Review and finalize Quality Agreements with partners/clients.
Handle pharmacovigilance documentation (via third-party support).

Required Skills:

Expertise in CIS, LATAM, EU, and African regulatory landscapes.
Strong understanding of regulatory systems (e.g., ANVISA, EMA, CDSCO).
Prior QC/analytical lab experience (esp. with HPLC) is a plus.
Proficient in regulatory writing and dossier compilation independently.
Strong coordination, analytical, and document management skills

Required Qualification: - B.Pharm/M.Pharm

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