Job Description

Oxford currently Looking for - Regulatory Affairs Officer for Mumbai H.Q.*

Roles and Responsibilities:

The Regulatory Affairs Officer will provide support to the Regulatory Affairs Manager and assist in -

Independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents, registration samples etc. for timely registration of the products. Preparation of Certificate of Analysis (COA) and other technical documents for Export. Any queries in this regard either from Authorities of these countries, directly or through country head, as well as from the manufacturers of such products should be coordinated by you. Maintaining Records related to regulatory documents Verifying dossier related documents received from plant, FnD or outside agencies Searching and Gathering documents of Innovator product. Should have knowledge for pharmacovigilance and will be coordinating with the pharmacovigilance service providers and maintaining the complete activities regarding pharmacovigilance.

Job Qualifications and Skill Sets:

A Pharma Graduate or Post Graduate with a minimum of 2-3 years of relevant experience in Pharma Industry Excellent written and verbal communication skills. Proficient in Microsoft Office (Word, Excel)

Website :

https://oxfordlab.com/

Job Type: Full-time

Benefits:

Flexible schedule Health insurance Leave encashment Provident Fund
Application Question(s):

What is your Current Annual CTC ? What are your expectations in terms of salary ? What is your Notice Period?
Education:

Bachelor's (Required)
Experience:

Regulatory reporting: 1 year (Required)
Work Location: In person