Head IRA
Job Description:
Job Description
Heading the regulatory department of the company and leading a team of executives/Senior executives/Asst.Manager.
- Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing,
guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of the
department.
- Coordination with plant for registration and other technical documents.
- Product development report, stability reports, process validations preparation & review.
- Analytical method validation review as per the ICH guideline.
- Drug Master File review.
- Guiding the team for FDCA applications and keeping a track of their timely renewals.
- Technical query response to the various regulatory authorities.
Further details ,please call +91-9510146364 or share cv-sangeeta@postaresume.co.in.
Key Skills :
Company Profile
Company is in man---fact---ring of finished prod---cts of pharma since last 14 years
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