Senior Regulatory Affairs Specialist

Scienta; United States; Remote; USD 135,000 - 170,000; Full time

Job summary

A leading regulatory consultancy is seeking a Senior CMC RA Consultant to support global regulatory submissions for biologics and advanced therapies. This dynamic remote role requires a seasoned professional to author high-quality CMC documentation and collaborate with regulatory agencies. Ideal candidates should possess a Master's degree and extensive industry experience, bringing a detail-oriented approach to managing multiple projects. Join a collaborative team dedicated to advancing life-saving therapies globally.

Qualifications

• 5-10 years in CMC regulatory industry or 3-5 years within a regulatory authority.
• Strong knowledge of FDA/EMA regulations and GMP standards.
• Self-driven and detail-oriented.

Responsibilities

• Author high-quality CMC regulatory documents aligned with development stages.
• Prepare meeting requests and responses to regulatory agencies.
• Review study designs for compliance and assess manufacturing changes.

Skills

Regulatory Compliance

Documentation Writing

Project Management

Collaboration

Communication

Education

Master’s degree in a life science field

Job description

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Scienta

Are you a seasoned CMC professional with a passion for biologics and advanced therapies? A leading regulatory consultancy is seeking a Senior CMC RA Consultant to support global regulatory submissions for biologic and cell & gene therapy products.

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 biologic product 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

  Health Care Provider and Quality Assurance

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

Referrals increase your chances of interviewing at Scienta by 2x

Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles.

Senior Manager, Regulatory Affairs (Remote)

Ohio, United States $145,000.00-$170,000.00 1 month ago

Sr Regulatory Affairs Specialist--Remote

Senior Regulatory Affairs Specialist, IVDR

Manager/Senior Manager/Associate Director, Regulatory Affairs (EDG-2025049)

Senior Manager, Global Regulatory Affairs

Senior Regulatory Affairs Quality Systems Specialist

United States $135,000.00-$155,000.00 1 day ago

Senior Regulatory Affairs Specialist, IVD

California, United States $47.00-$50.00 3 weeks ago

Senior Manager, Energy Policy and Regulatory Affairs

Airworthiness and Regulatory Affairs Manager

United States $148,000.00-$229,000.00 2 weeks ago

Senior Manager (Director), Regulatory Affairs & Pharmacovigilance, USA

Associate Director/Director, Regulatory Affairs

Sr Regulatory Affairs Specialist (Remote) - Shockwave

Santa Clara, CA $89,000.00-$165,600.00 6 hours ago

Sr Regulatory Affairs Specialist (Remote) - Shockwave

Santa Clara, CA $89,000.00-$165,600.00 1 day ago

United States $90,000.00-$133,000.00 6 hours ago

Regulatory Affairs Operations Senior Manager

United States $135,000.00-$150,000.00 4 days ago

Manager/ Senior Manager, Regulatory Affairs

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.