Job closed
Job description / Role
Responsibilities:
• Preparing submissions of products registration and renewals to strict deadlines;
• Ensuring that a company’s products comply with regulations;
• Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
• Negotiating with regulatory authorities for marketing authorization;
• Specifying storage, labelling and packaging requirements.
• Collecting, collating and evaluating scientific data that has been researched by colleagues;
• Developing and writing clear arguments and explanations for new product licenses and license renewals;
• Planning and developing product trials and interpreting trial data;
• Reviewing company practices and providing advice on changes to systems;
• Liaising with, and making presentations to, regulatory authorities;
• Monitoring and setting timelines for license variations and renewal approvals;
• Working with specialist computer software and resources;
• Writing clear, accessible product labels and patient information leaflets;
• Providing strategic advice to senior management throughout the development of a new product;
• Project managing teams of colleagues involved with the development of new products;
• Undertaking and managing regulatory inspections;
Requirements
Qualification:
• A Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, or Pharmacology.
• Minimum of 2 years experience in UAE and aware of it's regulation
• Must have experience in Cosmetics, skin care, beauty products
• Good time management skills, as a regulatory affairs specialist, must be able to work effectively in a demanding environment where strict timelines and protocols must be met
• Proficiency and familiarity with databases or other information management tools, since regulatory affairs specialists frequently work on managing and documenting information
• Excellent organizational and project management skills to frequently coordinate complex activities, often with competing priorities
• Well-developed analytical skills and the ability to pay particular attention to details
• Well-developed written and oral communication and interpersonal skills to frequently work with other employees and team members, and also advise others on compliance and regulatory matters
• Ability to join immediately
About the Company
A Leading Enterprise in the Middle East.