Urgent Job Opening-regulatory Affairs

1 week ago

Mumbai, India TopGear Consultants Full time

Hiring with a Pharmaceutical and Life sciences Company for their office in Mumbai

**Role: Regulatory Affairs**

**Roles & Responsibilities**:

- Evaluate the CMC documents received from alternate vendors of existing starting materials and intermediates for their adequacy. Design the control strategy and make appropriate submissions for the inclusion of these alternate vendors.
- Evaluate the cost improvement projects and finalise the filing category. Design the control strategy, notify customers and make appropriate submissions.
- Review and submission of New Drug Master Files (DMFs) in US, Europe, Canada, Japan and ROW markets.
- Revision and submission of amendments and updates of existing DMFs.
- Provide Regulatory support during Regulatory Agencies / Customer audits

**Knowledge and Skills**:
**Qualification: M.Sc. in Chemistry**

Current company name

Current CTC

Expected CTC

Notice Period

Role:
Healthcare & Life Sciences - Other
- Salary:
Not Disclosed by Recruiter
- Industry:
Pharmaceutical & Life Sciences
- Functional Area
Healthcare & Life Sciences
- Role Category
Healthcare & Life Sciences - Other
- Employment Type:
Full Time, Permanent
- Key Skills

regulatory affairs

Dmf

regulatory submissions

regulatory guidelines

US Market

CMC documents

RA

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

Company Profile
- Topgear Consultants
- Leading client is with TopGear Consultants Private Limited.

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