Regulatory Affairs Officer

Dossier preparation (both ACTD and CTD) and Submission for countries

Technical review of documents

Co-ordinate with QC, QA departments in plant for that documents and samples required for regulatory submissions.

Prepared samples and working standards for courier to clients for registration purpose.

Artwork review.

co-ordination with client and handle their quires related to product registration.

Preparation of apostille documents, Notary legalization Home, IMC (Indian Merchant Chamber)

Preparation of Renewals, Variations for the product.

Technical review of documents required for Regulatory agencies like DMF, Process

validation report and protocol, Analytical method validation report, pharmaceutical development report

Stability data, finished product certificate of analysis, finished product specification, Raw

material specification, Packaging material specifications etc,

Co-ordinate with R and D, QC, QA, ARDL. Departments in plant for that documents and

samples required for regulatory submissions.

Collect PVSS data from Regulatory Affairs Department and apply for COPP on online FDA site

Apply Product license and FSC.

Collect Documents and Filing of Tender list.

Check applications status on FDA site

Job Types: Full-time, Fresher

Benefits:

• Provident Fund

Schedule:

• Day shift

Ability to commute/relocate:

• Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• total work: 1 year (Preferred)