Hiring for Regulatory Affairs (US Market)
Position: Assistant Manager
Qualification:
M.Pharm/B.Pharm/M.Sc. with 10+ years of experience
Job Profile:
- Responsible for designated regulatory projects with respective deadlines
- Expertise in authoring CMC documentation for ANDA filings and post-approval submissions, with hands-on experience using eCTD software
- Good coordination skills with stakeholders to source documents in accordance with project timelines
- Review documents against FDA guidance to ensure regulatory compliance
- Keep knowledge up to date about regulatory guidelines
- Manage administration of regulatory documentation and ensure traceability of regulatory history (filing, archiving, database, etc.)
Position: Senior Officer/Executive/Senior Executive
Qualification:
M.Pharm/B.Pharm/M.Sc. with 4-7 years of experience in the US market
Job Profile:
- Author and compile CMC documentation for ANDA filings and post-approval submissions
- Coordinate with stakeholders to source documents in accordance with project timelines
- Review documents against FDA guidance to assure regulatory compliance
- Keep knowledge up to date about regulatory guidelines
- Hands-on experience using eCTD software
Email your resume to: nrane@centaurlab.com
