Regulatory Affairs Specialist Pharmaceuticals

We are looking for a Pharmaceutical Regulatory Affairs Specialist who isresponsible for all Product Classification and Product Registration and to ensure that all documents required are available and are submitted on

Location: Dubai

Responsibilities

• Registration of pharmaceutical and medical devices at DHA
• Studying scientific and legal documents

• Ensuring compliance with regulations set by DHA
• Maintaining familiarity with company product ranges
• Planning, undertaking and overseeing product trials and regulatory inspections
• Keeping up to date with changes in regulatory legislation and guidelines
• Analyzing complicated information, including trial data
• Offering advice about company policies, practices and systems
• Obtaining marketing permission
• Outlining requirements for labelling, storage and packaging
• Using a variety of specialist computer applications
• Liaising and negotiating with regulatory authorities
• Providing advice about regulations to manufacturers/scientists
• Writing comprehensible, user-friendly, clear product information leaflets and labels
• Ensuring that quality standards are met and submissions meet strict deadlines
• Preparing

Requirements

• Bachelor’s in science(Pharmacy will be an added advantage)
• Minimum of 4 years of experience in a similar role
• Excellent verbal and written communication skills
• Strong interpersonal skills and excellent customer service skills
• Highly developed attention to detail
• Strong project management skills
• Ability to work well in a team environment