Asst. Manager
Centaur Pharmaceuticals
- Posted: 20 hours ago
- Openings: 10
- Applicants: 0
Job Description
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)
More Info
Education
Any Graduate
Not Disclosed
Required Skills
Administration
Regulatory
anda
dbms
CIS
Coordination
ich
CTD
Contact Details
Centaur Pharmaceuticals
+91 987654567
Pharmacovigilance@centaurlab.com
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