Regulatory Affairs Associate

Regulatory Affairs Associate in Dubai, UAE for pharmacy graduates to play a key role in managing and executing affiliate-level regulatory affairs operations to support product lifecycle management and market access. This position is responsible for ensuring regulatory compliance throughout product registration, license maintenance, labelling updates, and post-approval activities, while aligning with local UAE regulations, Ministry of Health (MOH) requirements, and global quality systems. The role also supports operational excellence by maintaining accurate regulatory records and fostering effective relationships with regulatory authorities.

Job Responsibilities

• Support the execution of the affiliate Regulatory Plan in alignment with business objectives, local regulatory requirements, and global regulatory strategies.
• Assist in the preparation and submission of high-quality regulatory applications within defined timelines.
• Contribute to dossier preparation for new product registrations, line extensions, and new indications to obtain marketing authorizations.
• Coordinate administrative activities such as translations, notarizations, legalizations, and document formatting to facilitate dossier readiness.
• Execute post-approval maintenance activities, including renewals, variations, labeling changes, CMC updates, and periodic regulatory reports.
• Support dossier compilation and submission in full compliance with local regulations and internal quality system requirements.
• Monitor regulatory developments, guideline updates, and changes in the local regulatory landscape, communicating relevant updates to management and cross-functional stakeholders for timely implementation.

Regulatory Compliance

• Maintain accurate and up-to-date records within internal Regulatory IT systems and databases.
• Ensure all marketed products comply with applicable local regulations, MOH requirements, and global quality standards, applying the most stringent requirement where applicable.
• Maintain a complete and organized regulatory archive, ensuring current licenses, approvals, and product labels are readily accessible.
• Support the implementation of the local quality management system in alignment with global quality standards and local regulatory expectations.
• Participate in internal audits, self-inspections, and regulatory assessments in collaboration with Regulatory Quality teams.
• Proactively identify and escalate regulatory compliance risks and issues to leadership and relevant internal functions.

Labeling Responsibilities

• Act as Primary, Delegate, or Alternate Affiliate Labeling Responsible Person (ALRP), ensuring product information complies with local regulatory requirements.
• Manage the submission, approval, and implementation of updated product labeling within internal timelines and MOH-mandated deadlines.
• Follow global labeling procedures while documenting justified local exceptions to ensure alignment with global core labeling.
• Ensure accuracy, consistency, and regulatory compliance of all product information materials.
• Support effective implementation of eLabeling systems and ensure accurate maintenance of product information on approved eLabeling platforms.
• Support the implementation of internal regulatory initiatives aimed at improving efficiency, compliance, and operational excellence.
• Contribute to continuous improvement of regulatory processes and documentation practices at the affiliate level.

Personal and Professional Development

• Maintain strong knowledge of local UAE regulations as well as regional and global regulatory procedures.
• Participate in external regulatory training programs, workshops, and MOH meetings when available to remain updated on regulatory expectations and changes.

Job Qualifications

• Bachelor’s degree in Pharmacy or an equivalent scientific discipline.
• Strong written and verbal communication skills.
• Proficiency in computer applications and Regulatory IT systems.
• Good command of written and spoken English.
• Prior experience in regulatory affairs or a related role is highly desirable.
• Ability to adapt effectively to complex regulatory challenges and evolving requirements.
• Strong teamwork skills with a results-driven mindset.
• Excellent time management and organizational capabilities.
• Proven ability to build and maintain positive working relationships with internal stakeholders and external regulatory authorities.

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