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Manager - Regulatory Affairs & Quality Assurance
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Manager - Regulatory Affairs & Quality Assurance49
Applications
49
Applications
Not Accepting Applications
About the Job
Skills
JOB RESPONSIBILITIES
- Existing License management and compliances for manufacturing and trading units w.r.t. CDSCO, State FDA and FSSAI
- Import and Registration document preparation for CDSCO
- Preparation and review of DMFs in CTD format for export markets
- Overseeing Quality assurance activities at API and formulation units and preparation of plant related documentation including SMF.
- Performing Clinical review of existing products and conducting Clinical trials
- Generating and reviewing PSUR reports
- Assisting the PMT team for Clinical and regulatory inputs for products w.r.t marketing content, labelling etc.
- Maintenance and review of IPR approvals.
- Import and Export Clearance documentation preparation.
- Coordination with other departments for the smooth functioning of processes.
- Handling a team onsite and offsite.
- To perform APQR and plant audits.
- Any other duty assigned from time to time
QUALIFICATIONS:
1. Post Graduate in Lifesciences/Pharmacy/Medicinal Chemistry.
2. 5-6 years of experience in relevant field. Additional QA experience is preferred.
send your CV to office@prgpharma.com
About the company
Industry
Pharmaceuticals
Company Size
201-500 Employees
Headquarter
New Delhi
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