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Job vacancy for Regulatory Affairs & Analytical Research & Development at Hyderabad
- Regulatory Affairs
Experience: 2 to 3 years experience in Regulatory Affairs Department of any top pharmaceutical company.
Qualification: M. Sc or M. Pham
Job Description:
- Preparation, review, author dossiers/license applications for International markets
(USA, EU and Canada).
2. Publishing dossier with eCTD software for USA, EU and Canada markets.
3. Preparation, review, submission of license documents to State DCA, CDSCO offices and preparation of domestic applications
4. Active participation in the regulatory submission strategy designing.
5. Coordinating effectively with all cross functional teams
(QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of applications.
6. Providing Gap analysis, ensuring the accuracy, completeness, quality of documents available, conversion of existing dossiers as per the market specific requirements.
7.Evaluation of changes during post submission period, submission of Notification, post approval changes to the approved applications.
8. Good knowledge on D&C Act, 21 CFR, ICH and other regulations.
9. Provide guidance to manufacturing personnel about latest regulatory requirements
and cGMP requirements, fulfilling responsibilities of Regulatory personnel’s during inspections.
10. Effectively liaising with State DCA, CDSCO office personnel’s and counter parties.
2. Analytical Research & Development
Experience: 2 – 5 yrs.
Qualification: Master of Pharmacy – Pharmaceutical chemistry / Analytical chemistry
Master of Science – Analytical chemistry / Organic chemistry
Job Description:
- API Qualification analysis and report preparation
2) Analytical Method development and validation for finished products for regulated markets (US and Europe market)
3) Handling equipments like HPLC, UPLC, GC dissolution tester, UV/Vis
spectrophotometer, IR, KF titrator etc.
4) Trouble shoot in existing methods and support regular and stability analysis, Excipient
analysis for formulation development
5)Preparing reports like method development report, validation protocols and reports, specifications, stability protocols, stability reports etc.
6) Preparation of SOP’s & Calibration of analytical instrument
7) Support to Formulation & Analytical DoE analysis & Report preparation
8) Monitoring of safety in analytical Laboratory
9) Maintain GDP and GLP Practices, and Laboratory & Stores in an orderly manner.
Interested candidates can send their CV to
Email : hrd.hyd@defineplacement.com ,
rnd@defineplacement.com
