Regulatory Affairs Dossier Preparation (EU Market)

Althera Laboratories India Pvt Ltd, Bangalore

3 - 8 years

5 - 10 Lacs

bengaluru

Posted:1 week ago| Platform:

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Skills Required

regulatory affairs dossier preparation dossier cmc europe market document review

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title: RA Profile (EU Market Dossier Preparation)
Department:
Regulatory Affairs
Qualification:
Masters in Pharmacy
Reporting:
Manager Global Regulatory Affairs

Role & responsibilities

Regulatory submissions to the EU Market subsequently comply with applicable regulatory requirements.
Compile and review all documents required in line with the relevant guidelines. Coordinate with relevant departments and prepare submissions.
Perform detailed regulatory review and assessment of all documents, gather required data as needed to develop/finalise the documents, coordinate and prepare submissions
Review technical reports, summary documents and change controls (chemistry, manufacturing and analytical controls) for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments. Draft and review Product Information & labelling as required.
Prepare a version-controlled CMC write-up for the respective section.
Track Variation filings and approvals. Maintain the database.
Perform registration compliance reviews against quality documentation.

Preferred candidate profile

CMC Documents Review
Previous Experience with Emerging Markets Filing and Query & Response
Self-motivated, detail-oriented, and highly organised
Ability to collaborate and interact effectively with a variety of personnel
Excellent computer skills and Effective communication skills (written and verbal)
Proficiency in speaking, comprehending, reading, and writing English is required.
EU Dossier Preparation, Compilation and Technical Review of CMC Docs

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