Job Openings Sr. Executive - Regulatory Affairs

About the job Sr. Executive - Regulatory Affairs

Job Title: Sr. Executive - Regulatory Affairs

Job Location: Ahmedabad, Gujarat, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Skills:
Knowledge of regulatory requirements, Attention to detail, Strong communication skills, Project management, Ability to work under pressure, Research skills, FDA,

We are hiring for Sr. Executive - Regulatory Affairs.

Qualification: B.pharm/M.pharm

Experience - 2 to 5 years only

Location - Sola, Ahmedabad

Work mode - on site

Role responsibilities:-

  • Dossier preparation as per the ACTD CTD (Module I, II, III, IV and V) guideline.
  • Technical documents like Raw Material and finished products specification, manufacturing process,
  • Product development report, stability reports, process validations preparation review.
  • Analytical method validation review as per the ICH guideline.
  • Drug Master File review
  • Technical query response to the various regulatory authorities.

Market ROW: Africa, Latin America, Eastern Europe, the Middle East, and parts of Asia country exposure is required.

Thanks Regards,

Yesha (HR)

Mo- 98751 70543


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