API Regulatory Affairs - DMF Filing

Role - API Regulatory Affairs - DMF Filing / Compilation (Global market)

Level - Assistant Manager / Deputy Manager / Associate Manager Level : -

Required Education / Exp : -

Experience Req. : 7 yrs. - 15 yrs.

Qualification : - M.Sc. / M.Pharma

Responsibilities

1. Hands on Regulatory Affairs-API / DMF Filing / DMF Compilation / Submission / Customer Communication etc.

2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines.

3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes.

4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.

5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies.

6. Evaluation of change controls and updating to agencies by considering change categories.

7. Should have hands-on experience in eCTD software

Candidates with relevant exp., kindly share CVs to apply on : - rashmi.gupta@biocon.com

Kindly mention below details while sharing CV : -

• Total Exp?
• Current CTC?
• Total number of DMF filings?
• Handling which major markets globally ?
• Notice Period?
• Ready to work in Bangalore (onsite) ? (5 Days working)