Regulatory Affairs Officer

• 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