Senior Regulatory Affairs Strategist

Avetix Bio; Summit (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Avetix Bio is seeking a Senior Specialist, Regulatory Affairs to drive regulatory compliance strategies for products under development and marketed products. The role requires expertise in FDA/ICH guidelines and CTD documentation, with a focus on timely regulatory submissions and SOP governance within a fast-paced environment.

The ideal candidate will bring 5–7+ years of life sciences regulatory experience, strong project management, and the ability to adapt to evolving health authority

Qualifications

• Bachelor’s or Master’s degree in life sciences with regulatory experience.
• 7+ years (Bachelor’s) or 5+ years (Master’s) in regulatory compliance for pharma.
• Experience organizing responses to regulatory authority requests.
• US and international health authority submissions preferred.

Responsibilities

• Serve as regulatory affairs SME to the team and organization.
• Approve, review, or prepare CTD documents for regulatory compliance.
• Maintain compliance with US and international Health Authority regulations.
• Assist with developing regulatory strategy and responses to authority requests.
• Monitor regulatory changes impacting products and processes.
• Author/review SOPs and other regulatory documents.
• Perform special projects and duties as requested.

Skills

Regulatory affairs expertise

FDA/ICH knowledge

Regulatory submissions

Project management

MS Office

Document management

Attention to detail

Education

Bachelor’s Degree in life sciences

Master’s Degree in life sciences

Tools

CTD preparation

Microsoft Office

Job description

Avetix Bio is seeking a Senior Specialist, Regulatory Affairs to drive regulatory compliance strategies for products under development and marketed products. The role requires expertise in FDA/ICH guidelines and CTD documentation, with a focus on timely regulatory submissions and SOP governance within a fast-paced environment.

The ideal candidate will bring 5–7+ years of life sciences regulatory experience, strong project management, and the ability to adapt to evolving health authority