Regulatory Affairs Specialist III

Job Description

Job Summary:

• The Regulatory Affairs Specialist is responsible for supporting regulatory activities to ensure compliance with global regulatory requirements for products and processes.
• This role partners with cross-functional teams to facilitate timely submissions, approvals, and maintenance of regulatory documentation.

Duties and Responsibilities:

• Prepare, review, and support regulatory submissions (e.g., FDA, global regulatory bodies).
• Ensure compliance with applicable regulations, guidelines, and company policies.
• Maintain and update regulatory documentation and records.
• Support product registrations, renewals, and lifecycle management activities.
• Collaborate with R&D, Quality, Manufacturing, and Clinical teams to align regulatory strategies.
• Monitor and interpret regulatory changes and assess impact on products.
• Assist in audits, inspections, and responses to regulatory agencies.
• Contribute to process improvements and regulatory strategy development.

Qualifications:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related field.
• Experience in Regulatory Affairs within pharmaceutical, biotech, or medical device industry.
• Knowledge of FDA regulations, cGMP, and global regulatory requirements.
• Strong documentation, communication, and organizational skills.
• Ability to work in a fast-paced, cross-functional environment.