Overview

We are seeking a skilled and experienced Regulatory Affairs Manager to ensure that our products comply with all applicable regulations and guidelines. The Regulatory Affairs Manager will be responsible for preparing and submitting regulatory filings, as well as providing guidance and support to internal teams on regulatory matters.

Key Responsibilities

• Prepare and submit regulatory filings to relevant authorities.
• Monitor changes in regulations and guidelines and assess their impact on our products.
• Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
• Maintain regulatory documentation and databases.
• Participate in regulatory inspections and audits.

Required Skills

• In-depth knowledge of regulatory requirements and guidelines.
• Excellent writing and communication skills.
• Ability to work independently and as part of a team.
• Proficiency in regulatory affairs software.