Officer/Executive – RA

Job Description:

Position:          Officer/Executive – RA

Location:         Paria - Vapi

Experience:     2 - 5 Years

Industries:       Pharma

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

Salary :- Upto 6.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-