CMC Regulatory Affairs Consultant

About Freyr

Freyr Solutions is a global Regulatory Solutions and Services company supporting Life Sciences organizations across Pharmaceuticals, Biologics, Medical Devices, Consumer Healthcare, and related industries. Freyr provides end-to-end regulatory support across the product lifecycle, helping organizations navigate complex global regulatory requirements and successfully bring products to market.

Job Title: CMC Regulatory Affairs Consultant

Job Type: 12-Month Contract/Permanent

Job Location: Wilmington, Delaware – Hybrid/Onsite (3 days per week, non-negotiable)

Job Description

Freyr is seeking an experienced CMC Regulatory Affairs Consultant to support our client with global regulatory strategy and submission activities across large molecules, small molecules, and drug-device combination products.

The ideal candidate will bring strong hands-on expertise in developing CMC regulatory strategies, preparing and reviewing global regulatory submissions, managing Health Authority interactions, and providing strategic regulatory guidance to cross-functional stakeholders throughout the product lifecycle.

Role Overview

The CMC Regulatory Affairs Consultant will be responsible for developing and executing regulatory submission strategies and roadmaps while providing CMC regulatory guidance for development, registration, and post-approval activities.

This role requires direct experience with INDs, NDAs, BLAs, MAAs, Health Authority interactions, post-approval supplements/variations, renewals, annual reports, and drug-device combination product documentation.

The consultant will work closely with cross-functional stakeholders to ensure timely preparation, review, and completion of high-quality regulatory dossiers and responses to Health Authorities.

Key Responsibilities

• Develop and execute CMC regulatory submission strategies and regulatory roadmaps for assigned products.
• Provide strategic regulatory consultation and guidance to cross-functional teams throughout the product lifecycle.
• Prepare, review, and submit Pre-IND, IND, NDA, and BLA meeting requests and briefing packages.
• Prepare, review, and support submission of NDAs, BLAs, MAAs, and other global regulatory applications to Health Authorities.
• Manage and support interactions with global Health Authorities.
• Develop strategies and action plans for addressing Health Authority questions and information requests.
• Coordinate the preparation, review, and finalization of responses to Health Authority queries.
• Review device-related documentation and data to support successful submissions for drug-device combination products.
• Perform regulatory assessments of change controls and provide appropriate CMC regulatory strategy and guidance.
• Prepare and support post-approval supplements, variations, and other lifecycle management submissions.
• Track, prepare, review, and finalize renewal and annual report packages.
• Support regulatory activities associated with market expansion and registration of products in additional countries.
• Coordinate with internal and external stakeholders for the timely collection of documents and data required for regulatory dossiers.
• Ensure successful and timely completion of regulatory submissions and associated activities.
• Participate in cross-functional meetings and provide strategic regulatory guidance from a CMC perspective.
• Maintain effective communication and collaboration with Regulatory Affairs, CMC, Quality, Manufacturing, Technical Operations, Device, and other relevant functions.

Qualifications and Experience

• Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
• Strong hands-on experience in CMC Regulatory Affairs within the pharmaceutical and/or biotechnology industry.
• Demonstrated regulatory experience supporting large molecules and/or small molecules.
• Experience with drug-device combination products is strongly preferred.
• Strong hands-on experience developing regulatory submission strategies and roadmaps.
• Demonstrated experience with IND, NDA, BLA, and/or MAA submissions.
• Experience preparing and reviewing Pre-IND/NDA/BLA meeting requests and briefing packages.
• Strong experience managing and supporting Health Authority interactions and responses.
• Experience with global Health Authorities, including FDA and other major regulatory agencies.
• Knowledge of CMC lifecycle management, including change controls, supplements, variations, renewals, and annual reports.
• Ability to independently assess regulatory issues and provide practical, strategic recommendations.
• Strong stakeholder management and cross-functional collaboration capabilities.
• Excellent written and verbal communication skills.
• Ability to work effectively within a fast-paced, cross-functional regulatory environment.
• Must be able to work onsite in Wilmington, Delaware three (3) days per week. This requirement is non-negotiable.

What We Offer

• Opportunity to work on complex global CMC regulatory programs covering small molecules, large molecules, and combination products.
• Exposure to global regulatory submissions and Health Authority interactions.
• Collaboration with experienced regulatory, scientific, technical, and cross-functional teams.
• Opportunity to contribute directly to regulatory strategy and lifecycle management activities for global pharmaceutical products.

Why Join Freyr

At Freyr, you will have the opportunity to work on challenging global regulatory programs and collaborate with experienced professionals across the Life Sciences industry. You will contribute to regulatory strategies and submissions that support the development, approval, lifecycle management, and global expansion of pharmaceutical and combination products.