Job Title: Regulatory Consultant

Work Location: Remote-New England Area

Summary:

This contract position is responsible for supporting the preparation and execution of global regulatory submissions, with a focus on CMC (Chemistry, Manufacturing, and Controls) strategy. The role is a maternity leave backfill, requiring an experienced professional who can contribute immediately with minimal onboarding.

Responsibilities:

• Prepare and compile documentation packages for global regulatory submissions, including INDs, CTAs, Briefing Books, and Scientific Advice packages.
• Review and ensure accuracy of submission materials for regulatory agencies in the United States and internationally.
• Support the development and execution of regulatory strategies, risk assessments, and identification of regulatory issues.
• Contribute to the improvement of regulatory submission processes and procedures.
• Build and maintain collaborative relationships with internal and external stakeholders to facilitate regulatory activities.
• Participate in regulatory intelligence activities, monitoring guidelines and trends to advise project teams on their impact.
• Ensure compliance with FDA, EMA, and ICH guidelines for regulatory CMC submissions.
• Attend monthly onsite meetings as required and manage competing priorities in a fast-paced environment.

Qualifications:

• BA/BS or higher in a scientific or engineering discipline.
• 5 to 8 years of Regulatory CMC experience in biotech, pharma, or related fields such as manufacturing, analytical, or quality assurance, with strong dossier preparation experience for IND/CTA and BLA/MAA submissions.
• Experience with cell and gene therapy is strongly preferred.
• Comprehensive knowledge of FDA, EMA, and ICH guidelines, with the ability to apply regulatory CMC strategies for novel products.
• Strong experience with CTD format and content regulatory filings.
• Experience with diverse submission types, including drugs, biologics, and international filings, is preferred.
• Excellent organizational, written, and oral communication skills, with the ability to communicate complex issues clearly and concisely.
• Strong interpersonal skills, collaborative, easy to work with, and responsive in a cross-functional team environment.
• Ability to work independently, manage competing priorities, and exercise sound judgment.
• Willingness and ability to attend monthly onsite meetings as required.

Published Category: Regulatory Affairs