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Regulatory Affairs Executive

Job Summary

Regulatory Affairs Executive

  • Minimum Qualification: Bachelor
  • Experience Level: Executive level
  • Experience Length: 3 years

Job Description/Requirements

Position : Regulatory Affairs Executive

Report to : Regulatory Affairs Manager

Proposed of Position :

The Regulatory Affairs Executive works within the Regulatory Team to prepare and submit registration of pharmaceutical products, medical devices, foods and cosmetics. With the guidance form the Regulatory Manager, Regulatory Affair Executive advises and guides clients to prepare and ensure product registrations are maintained, and service levels are met

Job Description : 

  • Be responsible for and follow the agreed plan and timelines for Registration Projects to meet client and internal stakeholder objectives
  • Monitor and update the changes of regulatory affairs and government policies related to healthcare, and support the Regulatory Manager on Pharmacovigilance, and other regulatory affair matter as necessary
  • Ensure continuous knowledge update on the registration process for Pharmaceuticals, Supplements, Generics, Medical Device and Cosmetics in Myanmar
  • Work closely with internal and external stakeholders (i.e. Pharmacovigilance, Marketing, Finance, Regulatory Authorities) to ensure all the responsibilities and agreed services for the clients are meet
  • Understand and adhere to company's regulatory affairs SOP
  • Full understanding on the business models and key process related to Zuellig Pharma's operations and structure that will affect services and responsibilities
  • Support the Regulatory Affairs team for any regulatory affairs adhoc requests, not limiting to Product Review, Regulations, Guidelines
  • Promote and adhere to Zuellig Pharma's core values when carrying out day to day responsibilities and interactions

Qualifications : 

  • A bachelor's degree in science or equivalent experience in the healthcare industry

Requirements :

  • 3 years of working experience in related industry
  • Knowledge of Regulatory submission for pharmaceuticals and medical devices
  • Understanding regulations, acts and guidelines for registration, GMP, DGP, Pharmacovigilance
  • Understanding licensing and certification requirements for company, wholesales, distribution and maintaining these licenses and certificates
  • Understanding advertising guidelines and requirements
  • Good command of English both speaking and writing communication
  • Good at Microsoft office (word, excel, power point), Quest3+, preferable medcast

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| Full Time |
$ Confidential