Key duties of the job:
- Support global and regional regulatory activities
- Prepare and manage various submissions and correspondence to regulatory authorities ensuring adherence to national and international regulations and standards (e.g. FDA, Health Canada, European Union and Asia)
Qualifications and training required:
- Minimum of a Bachelor’s degree in a Science discipline is required – life science, biochemistry, pharmacy or chemistry preferred.
- Work Experience: minimum of 7 years of regulatory affairs in medical device/pharmaceutical drug development, preferably 2-3 years CMC experience.
- Demonstrable experience in successfully developing and managing regulatory submissions.
- 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