Regulatory Affairs Associate - MENAT (Temp - 1 year contract) - Dubai

Aspen Pharma Group; Dubai; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Specialist to ensure compliance with health regulations and manage the submission of regulatory documents. The ideal candidate will have a strong understanding of regulatory guidelines and experience in documentation management to support product approvals and compliance initiatives.

Qualifications

• Must have a degree in a relevant field.
• Experience in regulatory affairs is preferred.
• Strong understanding of regulatory requirements.

Responsibilities

• Execute regulatory affairs activities ensuring compliance.
• Compile and submit regulatory documents according to local requirements.
• Update regulatory trackers with accurate information.

Skills

Regulatory Compliance

Cross-Functional Collaboration

Document Management

Regulatory Documentation

Education

Bachelor's degree in relevant field

Job description

• Execute regulatory affairs activities to meet departmental and business goals while ensuring compliance with health authority regulations in assigned markets.
• Ensure alignment with the company’s internal procedures for regulatory standards.
• Define, determine, and communicate regulatory requirements and due diligence to stakeholders and project teams.
• Collaborate with cross-functional teams to manage the entire process from concept / development to artwork release for regulatory artwork changes.

REGULATORY & LABELLING RESPONSIBILITIES :

Regulatory Documents Submission :

• Compile and submit regulatory documents (new registrations, variations, etc.) according to local requirements.
• Ensure timely follow-up on submissions and manage timely deficiency responses.
• Prioritize high-margin products aligned with business objectives.

Regulatory Tracking :

• Update regulatory trackers with accurate information and provide input for regulatory plans.

Documents Archiving :

• Archive submitted dossiers (soft copies) in shared folders and Veeva RIMs as applicable.

Regulatory Guidelines Support :

• Develop a detailed understanding of regulatory guidelines and technical requirements for assigned countries.

Regulatory Plans Execution :

• Collaborate with the regulatory manager to develop and implement regulatory plans for complex projects (e.g., product transfers, life cycle maintenance, etc).
• Manage product and site renewals for the assigned markets by adhering to submission deadlines in the renewal tracker.

Cross Functional Support :

• Provide solutions to a variety of problems of moderate scope of complexity. Interacts with internal and / or external stakeholders. Identifies and responds appropriately to issues, providing adequate solutions.
• Work cross functionally on new products launches and products acquisition. Build better and stronger relationships with relevant internal and external stakeholders.
• Tender support with necessary information (as needed).

Labelling & Artwork Management (Local / Global IPs) :

• AW word files development, annotation and review of the artworks in compliance with local labelling guidelines ensuring quality control English version as well as the Arabic translation to have robust texts.
• Mock-ups creation to support various types of submissions (on the AW system or with 3rd parties).
• Artwork release post MOH approval and ensures all relevant stakeholders are informed as needed (on the AW system or with 3rd parties).
• Maintain AW tracker and archives for all the ongoing changes for the artworks.
• Abbreviated Product Information (API) review as needed.

Compliance :

• Ensure adherence to the company’s SOPs and work instructions.

RA Team Support :

• Work on assigned projects to assist other team members where needed based on the business priorities

Regulatory Guidelines Monitoring :

• Monitor changes in the healthcare regulatory environment and communicate updates to relevant stakeholders for implementation.