Job Description
Roles & Responsibilities
- Assist in the preparation and submission of regulatory documentation for new product registrations and variations, ensuring adherence to global health authority guidelines.
- Support the maintenance of regulatory databases and submission tracking systems, ensuring data accuracy and completeness for ongoing compliance.
- Conduct literature searches and gather scientific information to support regulatory submissions and respond to health authority queries.
- Review product labeling and promotional materials for compliance with applicable regulations and company policies.
Desired Candidate Profile
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related scientific field.
- Minimum of 1-2 years of experience in a regulatory affairs role within the pharmaceutical or medical device industry.
- Familiarity with global regulatory submission processes (e.g., FDA, EMA).
- Proficiency in using regulatory information management systems (RIMS) and document management systems.