Regulatory Affair Officers job at Abacus Pharma | Apply Now

Stay up-to-date on national and international regulatory requirements, including those of the FDA, EMA, and other relevant agencies.

Prepare and submit regulatory documentation, including applications for product registrations, marketing authorizations, and clinical trial approvals.

Manage and maintain accurate records of all regulatory submissions, approvals, and correspondence.

Liaise with regulatory authorities and respond to inquiries in a timely and professional manner.

Analyze regulatory trends and their potential impact on the company’s products and operations.

Participate in the development and implementation of regulatory strategies for new and existing products.

Review and approve labeling and packaging materials for compliance with regulatory requirements.

Participate in internal audits and ensure adherence to established regulatory procedures.

Contribute to the continuous improvement of the company’s regulatory processes.