Job Opening: Regulatory Affairs: Mumbai

1 week ago


Mumbai, India TopGear Consultants Full time

The Company Leading with Pharma and Chemical company for their office in Mumbai.

**Role: Regulatory Affairs: Mumbai**

**Job Description**:
**The position is responsible for Regulatory Affairs department where the person shall be responsible for the preparation, review and submission of API DMFs, LCM activities, Deficiency responses and customer support for the assigned molecules for global markets.
- DMF Submission:
Compilation, review and submission of the DMF's for various regulatory agencies across the globe including US, EU, Canada, Japan, TGA, Russia, China and other ROW markets.
- Life Cycle Management:
Compilation, review and submission of DMF Amendments, Annual Reports and Life Cycle management for all the regulatory filings as per regional requirement and to ensure the regulatory compliance.
- Deficiency Response

Evaluation of the regulatory queries and drafting, compilation and submission of the DMF Deficiency response/clarification received from various regulatory agencies.
- Customer Support

To address and provide customer support by providing the regulatory documentations including DMF AP, declarations, LOAs, customer queries etc.
- Change Management

Assessment of changes proposed and provide the regulatory strategy followed by customer notification and implementation.

Current Company
- Current CTC
- Expected CTC
- Notice Period- Role:
Pharmacist
- Salary:
Not Disclosed by Recruiter
- Industry:
Pharmaceutical & Life Sciences
- Functional Area
Healthcare & Life Sciences
- Role Category
Other Hospital Staff
- Employment Type:
Full Time, Permanent
- Key Skills

regulatory affairs

API

life cycle

regulatory compliance

change management

Deficiency response

RA

LCM

CMC

Regulatory Awareness

annual reports

dmf

WHO

Skills highlighted with ‘‘ are preferred keyskills
- Education
- PG:
MS/M.Sc(Science) in Any Specialization

Company Profile
- TopGear Consultants Pvt Ltd.
- Leading clients of TopGear Consultants Private Limited.



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