ManpowerGroup Middle East Hiring for Regulatory Affairs Specialist at Dubai Full Time

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.

Skills

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.