Regulatory Affairs Officer

1 day ago


Andheri West Mumbai Maharashtra, India Oxford Laboratories Pvt Ltd Full time

_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**:
**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



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