Deputy Manager- Regulatory Affairs (ROW)

Deputy Manager- Regulatory Affairs (ROW)

work outline icon6 - 12 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Shilpa Medicare Ltd

time outline iconHyderabad, Telangana, India

Posted on 04-07-2023

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1 Vacancy

Description

  • Assist in preparing response to regulatory authorities questions within assigned timelines.
  • Stay abreast of regulatory procedures and changes in regulatory climate. 
  • Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required. 
  • Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. 
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. 
    • Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

MPharm Industrial PharmacyMSc (Master of Science)BPharm (Bachelor Of Pharmacy)

Key Skills

Effective Communication SkillsProblem Solving SkillsDecision MakingTeam workingPreparationcompilation and review of dossiers RoW region in CTDcountry specific format

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