Sr. Executive

3 weeks ago


Ahmedabad, Gujarat, India Lifelancer Full time

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

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 and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/922ef7162212cb2aa47f851309c51db2

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