Regulatory Affairs

3 weeks ago

Karachi, Sindh, Pakistan 5G Healthcare (PVT) Ltd Full time
Regulatory Affairs & Pharmacovigilance OfficerRegulatory Affairs & Pharmacovigilance Officer

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Position: Regulatory Affairs & Pharmacovigilance Officer

About Us

At 5G Healthcare, we are a medical device manufacturing company committed to innovation, safety, and regulatory compliance. We develop high-quality medical devices that meet both national and international standards—contributing to better patient care and healthcare delivery.

We are currently looking for a Regulatory Affairs & Pharmacovigilance Officer to join our Regulatory team and help ensure that our products meet all legal and safety requirements from development to post-market surveillance.

Responsibilities

  • Prepare, compile, and submit regulatory documents, including CTD dossiers, for product registration and renewals
  • Communicate with local regulatory bodies to ensure timely approvals and responses
  • Monitor and report product safety issues in line with pharmacovigilance requirements
  • Maintain accurate regulatory records and documentation
  • Stay updated on relevant regulations and ensure internal compliance
  • Support regulatory inspections (e.g., DRAP audits) and respond to queries effectively
  • Work closely with QA, Production, and R&D teams to ensure regulatory alignment

Requirements

  • Education: Pharm-D
  • Experience: 2–3 years in regulatory affairs and pharmacovigilance, ideally in the medical device or pharmaceutical industry
  • Familiarity with regulatory procedures, dossier formats (especially CTD), and pharmacovigilance systems
  • Proficiency in MS Office
  • Strong written and verbal communication skills
  • Paid time off including vacation, sick, and emergency leaves
  • Health insurance (post-confirmation)
  • Reward and recognition programs
  • Supportive and flexible work environment

Apply Now: Send your resume to careers@5ghealthcare.com.pk Or WhatsApp us at 0341-5553371

#Hiring #RegulatoryAffairs #Pharmacovigilance #PharmaJobs #MedicalDevices #KarachiJobs #HealthcareCareers #PharmD #Compliance #5GHealthcare #JoinOurTeam

Seniority level
  • Seniority levelNot Applicable
Employment type
  • Employment typeFull-time
Job function
  • Job functionLegal
  • IndustriesMedical Equipment Manufacturing

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