Job Description

Job Summary:

The Medical Regulatory Affairs Executive will be responsible for managing regulatory submissions and ensuring compliance with national and international regulations for pharmaceuticals, medical devices, and related products. This role involves developing regulatory strategies, coordinating submissions, monitoring changes in regulatory requirements, and liaising with relevant authorities to facilitate timely approvals. The ideal candidate will have strong attention to detail, excellent communication skills, and a solid understanding of the regulatory landscape in the pharmaceutical or medical device industry.

Key Responsibilities:

• Regulatory Strategy and Compliance:
• Develop and implement regulatory strategies for new product registrations, renewals, and variations.
• Ensure all company products comply with applicable regulations, standards, and guidelines, including FDA, EMA, MHRA, TGA, and other relevant regulatory bodies.
• Maintain current knowledge of regulations, guidelines, and standards applicable to company products and proactively communicate relevant updates.
• Regulatory Submissions and Documentation:
• Prepare, compile, and submit regulatory documentation, including applications, dossiers, labeling, and technical documents, for regulatory approvals.
• Oversee and manage submission timelines, ensuring timely responses to regulatory agency questions and requirements.
• Conduct detailed reviews of labeling, promotional materials, and other documents to ensure regulatory compliance.
• Liaison and Communication:
• Act as a key contact with regulatory authorities, handling inquiries and maintaining positive relationships to facilitate approvals.
• Collaborate closely with cross-functional teams, including R&D, quality, clinical, and marketing teams, to ensure alignment on regulatory objectives and strategies.
• Support and guide internal teams on regulatory issues and compliance requirements.
• Risk Assessment and Change Management:
• Identify regulatory risks associated with product development and commercialization and provide recommendations to mitigate these risks.
• Manage changes to products, labeling, and other critical areas to ensure continuous compliance with regulations throughout the product lifecycle.
• Post-Market Surveillance and Reporting:
• Oversee post-market activities, including adverse event reporting, field safety notices, and recalls, if necessary.
• Ensure compliance with pharmacovigilance or post-market surveillance requirements.
• Documentation and Record Keeping:
• Maintain accurate records of regulatory submissions, correspondence, and related documents.
• Prepare and maintain regulatory reports, summaries, and presentations as needed.

Qualifications and Skills:

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
• Strong knowledge of regulatory guidelines and processes for major regulatory bodies (e.g., MOH-UAE, DOH, DHA, FDA, EMA, MHRA).
• Excellent organizational skills, with the ability to manage multiple projects and deadlines.
• Strong attention to detail and analytical skills.
• Proficiency in regulatory information management systems (RIMS) is preferred.
• Strong communication and interpersonal skills for effective collaboration with both internal teams and external regulatory agencies.

Job Location:

Dubai

Salary Range:

3000-5000

Job Type: Full-time

Pay: AED3,000.00 - AED5,000.00 per month