Regulatory Affairs Consultant I - Remote

Overview

Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in the area of Chemistry, Manufacturing, and Controls (CMC), with a focus on post-approval regulatory submissions. This remote role involves providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements.

In Short

• Lead and manage regulatory milestones for assigned products throughout the product lifecycle
• Contribute to strategic regulatory discussions and decision-making processes
• Develop and execute CMC regulatory strategies for post-approval pharmaceutical products
• Author and review global CMC submissions and supporting documentation
• Collaborate with internal teams and external partners for change management activities
• Coordinate responses to regulatory authority questions related to CMC content
• Manage regulatory operational activities and prepare submissions
• Conduct regulatory change control assessments
• Review technical documents related to drug development
• Maintain knowledge of FDA, EU, and global regulations

Requirements

• Bachelor’s or Master’s degree in Pharmacy, Biological Sciences, Engineering, or a related field
• Minimum 7 years of experience in CMC post-approval regulatory submissions
• At least 5 years of experience authoring CMC sections for post-approval filings
• Strong knowledge of US and European regulatory frameworks
• Experience in pharmaceutical development and drug product specifications
• Familiarity with cGMP environments and regulatory systems/tools
• Prior supervisory or team leadership experience preferred
• Excellent written and verbal communication skills
• Strong organizational and project management abilities
• Proactive, detail-oriented, and self-motivated

Benefits

• Award-winning company culture with emphasis on career growth
• Opportunities for professional development
• Engaging work environment
• Recognition for contributions and talents
• Competitive financial rewards