Key duties of the job:
- Leading all RA activities in the company and management of an RA Team responsible of international regulatory submissions
- Support global and regional regulatory activities
- Prepare and manage various submissions and correspondence to regulatory authorities ensuring adherence to international regulations and standards (e.g. FDA, Health Canada, European Union and Asia)
Qualifications and training required:
- Bachelor’s degree in a Science discipline– life science, biochemistry, pharmacy or chemistry preferred – Must
- M.Sc./PHD in any relevant field – an advantage
- Work Experience: minimum of 8 years of regulatory affairs in medical device/pharmaceutical drug development, preferably 5 years CMC experience.
- At least 3 years’ experience in leading a RA Team
- Prior experience with the preparation of CMC sections for regulatory submissions, as well as experience in registration of Device-Drug Combination Products (Class III) is highly desirable.
- Knowledgeable in FDA, EU, and/or Global regulatory submission processes is desirable.
- Exceptional organizational skills, ability to multi-task and be detail oriented.
- Ability to work well under pressure / Time management skills.
English – mother tongue level/high proficiency ONLY
