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.

Employment Type

• Full Time
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