Remote 505(b)(2) NDA Regulatory Strategist

Pharmatech Associates; San Francisco (CA); Remote; USD 120,000 - 150,000; Full time

Job summary

A leading regulatory consultancy seeks a highly experienced Regulatory Consultant to guide strategy and manage 505(b)(2) NDA submissions. The role requires at least 10 years of experience in regulatory affairs, specifically with FDA regulations and regulatory strategy development. This fully remote position is ideal for individuals with a strong background in global regulatory applications and excellent communication skills. Join a professional and inclusive team dedicated to ensuring successful product approvals for the pharmaceutical industry.

Qualifications

• Minimum 10 years of experience in filing global regulatory applications.
• Deep expertise in 505(b)(2) NDA submissions.
• Strong knowledge of FDA guidance documents.

Responsibilities

• Lead the development of regulatory strategies for product registration.
• Manage 505(b)(2) NDA submissions according to FDA guidelines.
• Serve as the primary contact with the US FDA.

Skills

Regulatory strategy development

FDA regulations knowledge

Project management

Regulatory submissions

Communication skills

Education

Advanced degree in science or biomedical engineering

Job description

A leading regulatory consultancy seeks a highly experienced Regulatory Consultant to guide strategy and manage 505(b)(2) NDA submissions. The role requires at least 10 years of experience in regulatory affairs, specifically with FDA regulations and regulatory strategy development. This fully remote position is ideal for individuals with a strong background in global regulatory applications and excellent communication skills. Join a professional and inclusive team dedicated to ensuring successful product approvals for the pharmaceutical industry.