Regulatory Scientist: IND/NDA Strategy & Submissions

SanegeneBio Inc.; Woburn (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

A biotechnology company in Woburn, Massachusetts, is seeking a highly skilled Regulatory Scientist to join their regulatory team. The role is critical for the preparation, submission, and management of IND and NDA applications to the FDA. The ideal candidate will possess strong analytical and project management skills, with a minimum of 5 years of experience in regulatory affairs, and expertise in FDA submissions. This position allows for collaboration with cross-functional teams to ensure compliance and successful drug development.

Qualifications

• 5+ years of experience in regulatory affairs.
• Proven track record of successful FDA submissions and regulatory agency interactions.
• Deep understanding of FDA regulations and the drug development process.

Responsibilities

• Develop and implement regulatory strategies for drug development.
• Lead the preparation and submission of IND and NDA applications.
• Serve as the primary contact for the FDA and other regulatory agencies.

Skills

Regulatory strategy development

FDA submission expertise

Analytical skills

Project management

Excellent communication

Education

Master’s degree in life sciences, pharmacy, or related field

Tools

Microsoft Office Suite

Regulatory submission software

Job description

A biotechnology company in Woburn, Massachusetts, is seeking a highly skilled Regulatory Scientist to join their regulatory team. The role is critical for the preparation, submission, and management of IND and NDA applications to the FDA. The ideal candidate will possess strong analytical and project management skills, with a minimum of 5 years of experience in regulatory affairs, and expertise in FDA submissions. This position allows for collaboration with cross-functional teams to ensure compliance and successful drug development.