Sr. Executive - Regulatory Affairs

Lifelancer


Date: 1 week ago
City: Gandhinagar, Gujarat
Contract type: Full time
About the JobSkillsKnowledge of regulatory requirementsFDAAttention to detailStrong communication skillsProject managementAbility to work under pressureResearch skills

We are hiring forSr. 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.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/2d6ebf5134d45b3a6f1b65524b69956f

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