Full-time
FoodTechSafety Jobs
Regulatory Affairs Associate vacancy to join a pharmaceutical regulatory Industry in Dubai, UAE. The successful candidate will play a critical role in supporting regulatory submissions, product registrations, lifecycle management activities, and regulatory compliance across the Middle East and North Africa (MENA) region.
The Regulatory Affairs Associate will work closely with the Regional Regulatory Affairs Manager, franchise teams, commercial departments, medical affairs, and external partners to ensure timely regulatory approvals and compliance with local and international pharmaceutical regulations. This role is ideal for professionals with experience in regulatory affairs, pharmaceutical registrations, dossier preparation, and MENA regulatory requirements.
Job Responsibilities
Regulatory Affairs Management
- Support the implementation of regulatory strategies aligned with regional business objectives and product launch plans.
- Provide regulatory guidance to internal stakeholders, including commercial, medical, marketing, and supply chain teams.
- Prepare, review, compile, and submit high-quality regulatory dossiers and registration documents in accordance with country-specific requirements.
- Ensure regulatory submissions comply with local health authority regulations and internal quality standards.
- Coordinate regulatory activities with regional and global regulatory teams for assigned product portfolios.
- Monitor and respond to regulatory authority queries within established timelines.
- Review regulatory guidelines, health authority updates, and scientific literature to support registration strategies.
- Build, customize, and distribute Common Technical Document (CTD/eCTD) dossiers for target markets.
- Maintain up-to-date knowledge of pharmaceutical regulations and technical requirements across MENA markets.
- Develop expertise in assigned therapeutic areas, products, and regulatory jurisdictions.
- Participate in regulatory intelligence activities and communicate relevant regulatory changes to stakeholders.
- Ensure regulatory compliance with company policies, SOPs, quality standards, and applicable regulations.
- Maintain accurate records of regulatory submissions, approvals, variations, renewals, and correspondence with health authorities.
- Track registration progress and regularly follow up with market access teams, distributors, and regulatory partners.
- Provide management with timely updates regarding regulatory submissions, approvals, and pending actions.
Regulatory Project Management
- Manage regulatory timelines and ensure submission milestones are achieved according to project plans.
- Maintain regulatory databases and tracking systems with current product registration status and approval timelines.
- Communicate regulatory approvals, commitments, and regulatory changes to internal and external stakeholders.
- Participate in cross-functional project teams supporting new product launches, lifecycle management, and business expansion initiatives.
- Represent assigned countries and product portfolios during regulatory meetings and project discussions.
- Collaborate with commercial, marketing, medical, quality assurance, and supply chain departments to support business objectives.
- Contribute to regional filing strategies and approval goals.
- Lead and support regulatory process improvement initiatives to enhance operational efficiency.
- Monitor key regulatory performance indicators and recommend corrective actions when required.
Compliance and Stakeholder Management
- Ensure adherence to local regulatory requirements, company policies, and international pharmaceutical standards.
- Support internal audits and regulatory inspections as required.
- Develop strong relationships with health authorities, distributors, and regulatory partners across the MENA region.
- Provide regulatory training and guidance to internal teams and external partners when necessary.
- Collaborate effectively with regional and global regulatory colleagues to achieve departmental objectives.
- Support the Senior Director of Regulatory Affairs and Regulatory Affairs Manager in delivering strategic regulatory initiatives.
Job Qualifications
- Bachelor’s Degree in Life Sciences, Pharmacy, Biotechnology, Pharmaceutical Sciences, Microbiology, Biochemistry, or a related scientific discipline.
- Master’s Degree in Life Sciences, Regulatory Affairs, Pharmacy, Business Administration (MBA), or a related field is preferred.
- Minimum 2 years of experience in Regulatory Affairs within a multinational pharmaceutical, biotechnology, healthcare, or life sciences organization.
- Experience handling pharmaceutical product registrations and regulatory submissions within the MENA region is highly preferred.
- Knowledge of GCC regulatory frameworks including UAE, Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, and other regional markets is advantageous.
Required Skills and Competencies
- Strong understanding of pharmaceutical regulatory affairs and registration processes.
- Experience with CTD/eCTD dossier preparation and lifecycle management.
- Knowledge of MENA pharmaceutical regulations and health authority requirements.
- Excellent project management and organizational skills.
- Strong analytical and problem-solving capabilities.
- Ability to manage multiple regulatory projects and meet strict deadlines.
- Excellent communication and stakeholder management skills.
- High attention to detail and regulatory compliance awareness.
- Proficiency in Microsoft Office and regulatory information management systems.
- Ability to work effectively in a cross-functional and multicultural environment.
Preferred Industry Experience
- Pharmaceutical Manufacturing
- Multinational Pharmaceutical Companies
- Biotechnology Organizations
- Healthcare and Life Sciences Companies
- Regulatory Consulting Firms
- Medical Devices and Healthcare Products Sector
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