Interested candidates kindly send your resume to the following email IDs: [email protected] & [email protected]
JOB DESCRIPTION- REGULATORY AFFIARS
Position: Asst. Manager
Qualification: M.Pharm /B.Pharm/M.Sc. having 8+ years’ experience in EU/ LATAM market
Job profile:
- Responsible for the designated regulatory projects with respective deadlines
- Expertise in authoring CMC documentation for EU MAA and post-approval submissions with hands-on experience on using eCTD software
- Good coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines
- Review the documents against the Agency guidances assuring regulatory compliance
- Keep knowledge up to date about regulatory guidelines
- Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)
