Executive - Regulatory Affairs - EM Market
S S Pharma · Gurugram · onsite · Posted 31d ago
Undisclosed0–6 yrsfulltimeSourced from
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About this role
Job Summary
Regulatory submission of new products, variations, response to queries, Life cycle management for WHO Sub Sahara Africa markets through preparation of quality dossiers enabling timely approvals.
Area Of Responsibility
Area Of Responsibility
1 . New submissions:
a. Review prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
b. Review documents (Development report, scale up report, specification, stability protocol), artworks etc.
before initiation of Exhibit batches for adequacy.
2. Approval:
Review prepare response to deficiency enabling approval of products filed to regulatory agency.
3. Lifecycle management for drug formulations:
a. Prepare and review variations as per the country requirements to support approval of changes such as API
vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
b. Prepare and review re-registration/PCH dossiers submit the same to regional office/ regulatory agencies
4. Regulatory compliance:
a. Prepare, Review and circulate approval package to stake holders upon receipt of approval and update the
same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
rosRegulatory AffairsChemistryRegulatory ComplianceManufacturingcompliance
About S S Pharma
S S Pharma
25
employees
Mumbai
US
₹4L PA avg
Avg at S S Pharma
About
Sun Pharmaceutical Industries Ltd.
Industries
Healthcare / Pharma
Employee ratings
7 reviews
3.9/ 5
Culture
3.5
Career growth
3.5
Work-life
3.7
Employees rate it well for
Overall Company39Work-Life Balance38
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