Regulatory Affairs Officer

Job Summary

The senior Regulatory Affairs Officer is responsible for obtaining and maintaining the registration of

products in the ministries of health to enable sales in the region and ensuring products meet legislative

requirements by proper handling of the documentation.

Basic Function

• Contact suppliers and request the supporting documents for any
• product registration/renewal.
• Review, arrange, and submit the presented documents for DM, SFDA
• and initiate the registration process.
• Review, arrange, and share the documents with sub distributors in
• countries other than UAE & KSA.
• Communicate the successful registration once completed.
• Assist the logistics team in clearing shipments in the port promptly.
• Liaise and negotiate with regulatory authorities.
• Maintain familiarity with company product ranges and keep up-to-date
• with changes in regulatory legislation and guidelines.
• Ensure compliance and adherence to the Health authority’s rules and
• regulations at all times.
• Keeping updated trackers for registered products and under.
• registration & products variation per country.
• Keeping and updating full-year registration plan per country.
• Keeping all the documents in the archive.
• Creating spreadsheets for all the countries.
• Maintaining knowledge of current regulations applicable to each country.
• Strong analytical, data analytics, and data management skills.
• Excellent interpersonal, verbal, and written communication skills.
• Self-motivated with the ability to work independently as well as in a
• team, and comfortable in a dynamic environment.
• Excellent verbal and written communication in English and Arabic.
• Knowledge of applicable government regulations in MENA Region.
• Must possess basic computer skills and Microsoft Office.
• Strong organizational and time management skills.
• Strong commercial awareness and negotiation skills.
• Meticulous and attention to detail.
• Decision-making skills.
  

Education

Bachelor's degree in Science, Chemistry, Pharmacy, or any related field.

Experience

0-2 years of experience in the Regulatory Affairs field.