2 - 7 years
3 - 8 Lacs
Posted:16 hours ago|
Platform:
Work from Office
Full Time
-Plan, prepare and review of high-quality eCTD dossier within stipulated timelines for submission in regulated markets like EU/Australia/Canada/UK/ South Africa.
-Preparing query responses for submission to regulatory agencies and clients, within the stipulated timelines.
- Preliminary review of the In-licence dossier and preparation of the due diligence report.
-Co-ordination with cross-functional teams at manufacturing plant and RnD for retrieving documents and any matters related to the submission.
-Technical review of GMP documents and RnD documents for submission purpose.
-Hands on experience with eCTD software and be able to compile eCTD sequence for EU/Australia/Canada/UK/ South Africa markets.
-Exhibiting good and up-to-date knowledge of ICH/EMA guidelines and regulations for submission in the regulated markets of EU/Australia/Canada/UK/ South Africa.
-Ensuring product compliance throughout its lifecycle via any necessary post approval regulatory notifications/variations.
-Monitoring and interpreting regulatory guidelines and staying up-to-date with evolving legislation and guidelines.
-Should have good verbal and written communication skills.
-Should have a positive attitude and be a team-player.
- Note - Candidate can also call on 6357410551-Bhargav Dalal- HR.
Biomatrix Healthcare
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