Regulatory Affairs Specialist

Posted Date 9 months ago
Location United Arab Emirates
Discipline Pharmaceuticals
Job Reference 31501
Salary 0.0

Contract Duration: 1 year (renewable)

Job Responsibilities:

  • Evaluate, prepare and submit drug registration applications and follow through the application during the evaluation phase to achieve a favorable outcome.
  • Prepare applications for registration of new products, variations to marketed products and renewals, where required.
  • Assist with responses to deficiency letters and other requests for data from Saudi Food and Drug Authority.
  • Maintain registration of currently approved products.
  • Develop and maintain good working relationships with internal departments, health authorities and industry bodies.
  • Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products.
  • Develop packaging for new and existing products and comply with government regulations.
  • Review labelling and product information for compliance with relevant regulations and codes.
  • Liaise with manufacturing sites when required.
  • Update the pharmaceutical company's regulatory systems.
  • Authoring and reviewing standard operating procedures (SOPs) related to regulatory activities.
  • Reviewing and approving promotional and non-promotional materials.
  • Processing with any regulatory tasks.
  • Support in the business transition activities.
  • Support in initiating, processing, and archiving purchase orders and update the systems for regulatory payments.
  • Ensure that all regulatory trackers and systems are updated.

Requirements:
  • Bachelor’s degree in pharmacy science or equivalent
  • Minimum of 3-4 years of work experience in the pharmaceutical industry (regulatory operations, compliance, due diligence, labelling).
  • Excellent communication skills in English and Arabic is a big plus.
  • Well versed in reporting and maintaining trackers.
  • Proficient in MS Office tools and other systems.
  • Knowledge of the pharmaceutical industry practices and global anti-bribery laws is highly preferred.