Reqd Regulatory Affairs - Sr Officer/Exe- Pharma API Business

Exemed

3 - 5 years

3 - 5 Lacs

vadodara

Posted:4 hours ago| Platform:

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Skills Required

regulatory guidelines new drug applications snd ich usfda apis. cdsco ra impurity profiling characterization regulatory affairs dossier ema global regulatory guidelines api chemistry characterization nitrosamine impurity assessment interdepartmental coordination

Work Mode

Work from Office

Job Type

Full Time

Job Description

Company Name: Oneiro Lifecare Pvt Ltd

Designation: Regulatory Affairs - Sr Officer/Executive - API

Location- Ekalbara Plant (Vadodara)

Preferred candidate profile

3 to 5 Years (M.Pharm

JOB PROFILE

Interdepartmental Coordination:
Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions.
API Chemistry & Characterization:
Provide expert input on
molecular chemistry
, including
impurity profiling
,
characterization
, and
Nitrosamine impurity assessment
.
DMF (Drug Master File) Management:
Prepare, maintain, and update
DMFs (both Open and Closed Parts)
for submission to national and international regulatory authorities.
Ensure data integrity and compliance with
ICH and other global regulatory guidelines
.
Regulatory Documentation & Submissions:
Prepare, review, and submit
CDSCO-specific checklists
for
New Drug Applications (ND)
and
SND (Subsequent New Drug)
filings for APIs.
Regulatory Compliance:
Stay current with evolving regulations and guidelines issued by
CDSCO, ICH, USFDA, EMA
, and other global regulatory bodies.
Assist in audits and regulatory inspections by preparing and presenting required documentation.
Liaison with Regulatory Authorities:
Coordinate with
Local FDA
&
CDSCO
Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication.

corporate.hr@exemedpharma.com

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