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8 Europe Jobs in Hyderabad / Secunderabad

Regulatory Affairs Executive/ Asst. Manager

3-8 years

Hyderabad / Secunderabad

10 vacancies

Regulatory Affairs Executive/ Asst. Manager

Hetero

posted 30min ago

Job Role Insights

Flexible timing

Job Description

Job Description:

  • Keen Knowledge on Regulatory guidelines for finished product registration.
  • Dossier compilation as per EAEU guidelines.
  • Compilation and review the product dossiers for submission in CTD, ACTD.
  • Gap analysis of the dossier and addressing the gaps before submission to MOH.
  • Handling the customer and MOH queries.
  • Life cycle management of the product.
  • Development report, scale up report, specification, COA, stability protocol and Process validation protocol.
  • Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
  • Post approval experience to file the applicable variations timely.
  • Knowledge on EAEU, ICH and EMEA guidelines.
  • Re-registration (Renewal) procedures.
  • Administrative documents requirements (COPP, Mfg. License and Import License) .
  • Registration information management system updates on regular basis.



Employment Type: Full Time, Permanent

Read full job description

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