RA Executive

Quality HR Services

5 - 6 years

6 - 7 Lacs

raigarh

Posted:1 day ago| Platform:

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Skills Required

cgmp ich starters regulatory affairs regulatory guidelines ectd regulatory submissions usfda anda regulatory documentation dossier regulatory compliance dossier preparation ra tga ctd qc quality assurance mhra product registration dmf actd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Dossier Preparation & Submission
Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets.
Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and formulations.
Ensure accuracy and completeness of Module 15 in line with specific regulatory authority requirements.
Regulatory Compliance & Communication
Ensure continuous regulatory compliance of products as per cGMP and ICH guidelines.
Review and submit annual reports, amendments, variations, and renewals as required.
Communicate with regulatory agencies and address queries, deficiencies, and clarifications (Q&A) in a timely manner.
Documentation & Data Collection
Coordinate with R&D, QA, QC, Production, and Supply Chain teams to gather necessary technical documents.
Maintain and update regulatory databases, trackers, and registration status reports.
Change Control & Lifecycle Management
Evaluate regulatory impact of change controls and ensure timely submission of variations.
Support post-approval submissions and product updates in different markets.
Audit & Inspection Support
Provide regulatory support during internal and external audits (e.g., USFDA, MHRA, WHO-GMP).
Maintain audit-ready regulatory documentation.

Required Skills

In-depth knowledge of
regulatory guidelines
(USFDA, EMA, MHRA, WHO, TGA, CDSCO)
Experience in
dossier preparation and submission formats
(CTD, eCTD, ACTD)
Strong understanding of
cGMP, ICH, and global registration processes
Good command of
technical writing and documentation
Excellent coordination and communication skills
Attention to detail and a strong sense of compliance

Required Qualification:

B.Pharm/M.Pharm

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