Regulatory Affairs Executive

20 hours ago

Vadodara Gujarat, India Ami Lifesciences Full time

**Role & responsibilities**
- EU Dossier preparation and submission to Europe market.
- EU ASMF and CEP preparation and submission to Europe with post-approval activities
- Handling of EDQM Agency Queries.
- Brazilian DMF Preparation and Deficiency response.
- China DMF Preparation and Deficiency response.
- eCTD publishing in EDUCE software with PDF processing of documents.
- Cross-Functional Team leading for project completion.
- Preparation, Review, Submission, and Life Cycle Management of USDMF.
- Preparation, Review, Submission, and Life Cycle Management of ANDA.
- Handling of USFDA Agency Queries.
- Preparation and Review of Product Label and Pack-insert.
- Customer correspondence for regulatory requirements.
- Regulatory documents preparation like Applicants part, Restricted part, technical packages, and technical information to customers.
- Review of Regulatory Documents like TTD, AMV, PDR, Characterization report, Change control etc.
- Markets Handled: USA, Europe, Canada, Brazil, other ROW etc.
- Must experience in API Industry.
- Qualification: B.Sc / M.Sc Chemistry, B.Pharma / M.Pharma
- Role:_Regulatory Affairs Compliance
- Salary:_ Not Disclosed by Recruiter
- Industry:_Pharmaceutical & Life Sciences
- Functional Area_Legal & Regulatory
- Role Category_Corporate Affairs
- Employment Type:_Full Time, Permanent
- Key Skills
- CTDdmf
- Skills highlighted with ‘‘ are preferred keyskills

Education
- PG:_MS/M.Sc(Science) in Organic Chemistry,M.Pharma in Any Specialization

**Company Profile**:
Ami Lifesciences

**Ami Lifesciences was incorporated with the goal of changing the way in which quality medicines are delivered to people in need. We operate on the principle by extending our focus and services to maximize our impact on the global pharmaceutical industry.**

**We have spent last two decades in building up our scientific and technological capabilities, research, and manufacturing competencies. Along the way we have earned a reputation for being innovative, inventive, and resourceful. We have built long term business association pharmaceutical companies of the world.

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