Senior Regulatory Affairs Specialist

Scienta; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

A leading regulatory consultancy is seeking a Senior CMC Consultant to support global regulatory submissions for small molecule assets. This remote position offers a collaborative environment where you will author key regulatory documents and prepare briefing packages, ensuring compliance with FDA/EMA regulations. Ideal candidates have strong writing skills and CMC experience, with a master's in life sciences. Join the team to help innovate and support life-saving therapies.

Qualifications

• 5-10 years in industry focusing on CMC regulatory or 3-5 years within a regulatory authority.
• Self-driven and adept at managing multiple projects.

Responsibilities

• Author high-quality CMC regulatory documents aligned with development stages.
• Prepare responses and briefing packages for regulatory agencies.
• Assess manufacturing changes for regulatory impact.

Skills

Strong knowledge of FDA/EMA regulations

Excellent writing skills

Collaboration skills

Detail-oriented

Project management

Education

Master’s degree in life sciences

Job description

Direct message the job poster from Scienta

Senior CMC Consultant (Small Molecule) – Remote

Are you a seasoned CMC professional with a passion for small molecules? A leading regulatory consultancy is seeking a Senior CMC RA Consultant to support global regulatory submissions for innovative small molecule assets.

Key Responsibilities:

• Author high-quality CMC regulatory documents (Module 3) aligned with various development stages.
• Prepare and deliver meeting requests, briefing packages, and responses to regulatory agencies.
• Review early-phase study designs for compliance with regulatory expectations.
• Assess manufacturing and quality changes for regulatory impact and prepare comparability reports.

Requirements:

• Master’s degree in a life science field (or equivalent experience).
• 5-10 years in industry focussing on CMC regulatory or 3–5 years within a regulatory authority.
• Strong knowledge of FDA/EMA regulations and GMP standards.
• Demonstrated excellence in writing clear, compliant, and well-structured CMC documentation.
• Self-driven, detail-oriented, and adept at managing multiple projects independently.
• Strong collaboration and communication skills.

This is a dynamic opportunity to work on innovative therapeutic programs while enjoying the flexibility of a remote position. You’ll be part of a collaborative team helping bring life-saving therapies to patients worldwide.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Health Care Provider

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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