Associate Manager, RA1 – Regulatory Affairs

About the role

The Associate Manager, RA1, will support the development and execution of regulatory strategies for medical products across their lifecycle, ensuring compliance with local, regional, and global requirements.

Key responsibilities

• Assess regulatory intelligence and contribute to local, regional, and global regulatory strategies.
• Provide regulatory advice throughout product concept, development, manufacturing, and marketing phases.
• Identify and mitigate regulatory obstacles, develop solutions, and negotiate with authorities.
• Determine submission requirements, approval pathways, and compliance activities for multiple jurisdictions.
• Prepare and submit electronic and paper regulatory dossiers and monitor authority review processes.
• Support cross‑functional teams with regulatory guidance on quality, pre‑clinical, clinical data, labeling, and post‑marketing surveillance.

Required profile

• BS in Engineering, Science, or related field; MS in Regulatory Science preferred.
• Minimum of 6 years of experience in regulatory affairs, preferably with MS or RAC certification.
• Demonstrated ability to develop regulatory strategies, manage submissions, and interact with regulatory authorities.