Regulatory Affairs Officer (Panchkula)

Regulatory Affairs Officer (Panchkula)

04 Aug
|
TalentXplore
|
Panchkula

04 Aug

TalentXplore

Panchkula

- Assist in the preparation and review of regulatory dossiers in CTD/eCTD format for submission.

- Support in the compilation of documentation for Recent Marketing

Authorizations, Post-Approval Variations, and Renewals.

- Coordinate with departments such as QA, QC, Production, R&D;, and

Packaging for data collation and timely submission.

- Review and verify product labeling, SmPCs (Summary of Product

Characteristics) and artworks as per MHRA requirements.

- Track and manage regulatory submission timelines and maintain regulatory submission records.

- Assist in compiling response packages for deficiency letters / queries from

MHRA.

- Support audits and inspections by MHRA by providing required regulatory documentation.

- Maintain awareness of changes in regulatory guidelines and communicate updates internally

📌 Regulatory Affairs Officer (Panchkula)
🏢 TalentXplore
📍 Panchkula

Reply to this offer

Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.

Subscribe to this job alert:

Get the latest job offers by email for: regulatory affairs officer (panchkula) / panchkula

Subscribe to this job alert:

Get the latest job offers by email for: regulatory affairs officer (panchkula) / panchkula