Executive Regulatory Affairs

2 weeks ago

Thane, India Bazillion Full time

**Executive Regulatory Affairs (API Pharma)**

**Qualification**: M.Sc. - Organic & preferably diploma or must have worked in Regulatory Affairs department of Pharmaceutical Organization / API

**Experience** : 8 - 10 years in Quality Assurance department (QA) of Pharmaceutical Industry & regulatory Affairs department ,preferably from API Pharma industry.
- Must be familiar with Quality Assurance department functioning viz. CGMP, Q7 ICH guidelines, GLP.
- Must be able to handle Regulatory affair department functioning independently.
- She must be able to prepare Drug Master File (DMF) - Applicant Part (AP) & Restricted Part ( RP ) independently ,
- should be able handle DMF related company’s & Regulatory Authority’s queries.
- should be able to support our Marketing & Export departments with their documentary requirements related to regulatory affairs & Export oriented organizations
- Should be able to lead & guide a Team of 5 - 6 Officers / Executives of QA Department.

**Location:

- Dombivly**

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹500,000.00 - ₹600,000.00 per year

Schedule:

- Day shift

Application Question(s):

- Are you ready to work in Dombivly location?
- Current CTC?

Expected CTC?

**Experience**:

- Regulatory Affairs department of Pharma Industry(API): 1 year (required)
- Preparing of DMF ,AP & RP: 1 year (required)
- Marketing & export documentary requirements related to RA: 1 year (required)
- Team management: 1 year (required)

**Speak with the employer**
+91 9970036509

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