Regulatory Affairs

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Regulatory Affairs

work outline icon2 - 8 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Hetero Drugs Limited

time outline iconHyderabad, Telangana, India

Posted on 18-05-2023

1 Vacancy

Description

  • Walk-In Interview
  • Date: 20th May, 2023
  • Time: 9.00 a.m. to 3.00 p.m
  • Venue: Hetero Labs Limited, Unit VII Plot No:14, Jeedimetla, Qutubullapur(M), Medchal Dist., Hyderabad. T.S
  • Markets: ROW, EU, US.
  • Keen Knowledge on Regulatory guidelines for finished product registration. 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.
  • Compilation and Submission of ANDA's & EU dossiers.
  • Post & Pre approval experience to file the applicable variations timely.
  • Knowledge on EU, ICH and EMEA guidelines.
  • What to bring to the interview:
  • Academic documents, pay slips, appointment letters. CTC particulars and ID proof.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)

Key Skills

Attention to DetailCommunicationRegulatory AffairsProblem Solving SkillsTeam Work

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