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Regulatory Affairs Assistant Manager / Sr. Executive
Aura LifeCare
posted 7d ago
Job Description
- Dossier preparation as per CTD/ACTD/eCTD/Regional guidelines.
- To co-ordinate with plant team i.e. QA, QC, Production department for availability of technical & legal documents in the given time-line.
- Review of documents received from plant team and co-ordinate with respective departments in case of any discrepancies.
- Review of dossiers prepared by team-mates.
- To ensure that the registration samples be available as per pre-defined time-frame.
- Submission of response to Queries / Deficiencies raised by Customers / Regulatory Authorities within timeline.
- Artworks review & approval
- Co-ordination with Clients / Customers for the registration updates, plant approval process etc.
- To maintain & update the records for all submissions & regulatory related activities
Employment Type: Full Time, Permanent
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What Aura LifeCare employees are saying about work life
based on 25 employees
Strict timing
Monday to Saturday
No travel
Day Shift
Aura LifeCare Benefits
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