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