Regulatory Affairs Associate

Regulatory Affairs Associate at Intrinseque Health

Key Responsibilities

• Managing regulatory affairs activities for clinical and healthcare-related products.
• Preparing and reviewing regulatory documentation and submission dossiers.
• Ensuring compliance with applicable regulatory requirements and guidelines.
• Supporting regulatory submissions, including product registrations and renewals.
• Maintaining product registration records, licenses, certificates, and documentation.
• Coordinating with internal teams and external regulatory authorities.
• Tracking changes in applicable regulations and supporting the implementation of necessary changes.
• Assisting with regulatory audits and responses to regulatory queries.

Requirements & Tech Stack

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• Experience in Regulatory Affairs (RA), preferably in the pharmaceutical, medical device, or clinical healthcare industry.
• Knowledge of regulatory documentation, submissions, and compliance requirements.
• Strong documentation, communication, and coordination skills.