Regulatory Affairs Executive
4 months ago
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The Role
Job Description:-
- Dossier preparation as per the ACTD & CTD (Module I, II, III, IV, and V) guidelines.
- Technical documents like Raw Materials and finished products specification, manufacturing process,
Product development report, stability reports, process validations preparation & review.
- Analytical method validation review as per the ICH guideline.
- Drug Master File review
- Technical query response to the various regulatory authorities.
Ideal Profile
- You have at least 1 year post-qualification experience in a similar role.
What's on Offer?
- Opportunity to make a positive impact
- A role that offers a breadth of learning opportunities
- Work in a company with a solid track record of performance
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