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Officer Regulatory Affairs - Canada - Pune

1 - 4 years

2 - 4 Lacs

Pune

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Canada ANDS Regulatory Affairs RA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role: Regulatory Affairs Canada Job location: Pune, Wakad Experience: 1-4 Years JD : 1. Experience in Canada market is required 2. Involved in Dossier preparation, Submission, Compilation of NDS/ANDS, Query Response for all dosage forms. 3. Modulewise documents review in line with eCTD guidelines 4. Responses for screening deficiencies. 5. Gap Analysis 6. Should have good knowledge and understanding of ICH and ANDS guidelines. 7. Hands on experience for review of various documents such as specifications, method of analysis, analytical method validations, product development reports, stability protocols etc. 8. Knowledge of DocuBridge software is preferred. If relevant and interested, pls share your resume

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www.emcure.co.in

Pharmaceuticals

Pune

Over 5,000 Employees

54 Jobs

    Key People

  • Satish Mehta

    Managing Director

  • Dinesh Mehta

    Chairman

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