Asst. Manager (India)

Asst. Manager (India)

30 Jul
|
Centaur Pharmaceuticals
|
India

30 Jul

Centaur Pharmaceuticals

India

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

- Positive 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)

📌 Asst. Manager (India)
🏢 Centaur Pharmaceuticals
📍 India

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