Regulatory Affairs Consultant, CMC – Biologics

Parexel•Southport, NC

8d•Remote

About The Position

Parexel is seeking a remote Regulatory Affairs Consultant, CMC – Biologics, to provide CMC regulatory strategy input and expertise for investigational, new, and marketed biologic and small molecule drug products. The role helps ensure products are developed and maintained in compliance with global regulatory requirements and guidance, with primary responsibility for the US, EU, and Canada, supporting timely approvals and continued marketing. The consultant supports regulatory compliance, prepares CMC and GMP documentation for health authority submissions, and supports health authority CMC meetings. The role collaborates with Regulatory Affairs leads and cross-functional partners in manufacturing, quality, Technical Operations, affiliates, and external organizations. It contributes to regulatory strategy from early development through post-approval changes, including preparing and reviewing submissions, representing CMC Regulatory Affairs in project team meetings, and supporting monthly global CMC GRT meetings. The position is part of a fast-paced, growth-oriented environment focused on high-quality submissions, strategic regulatory input, and continuous improvement.

Requirements

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.
4–6 years of CMC experience in the pharmaceutical industry, with a history of successfully preparing regulatory filing documentation.
Comprehensive knowledge of the drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues.
Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products.
Comprehensive knowledge and experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for the FDA and equivalent submissions for Europe and Canada.
Comprehensive understanding of the global regulatory environment.
Demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook.
Strong analytical, problem-solving, organizational, and negotiation skills.
Experience working in the pharmaceutical industry within a regulated environment.
Strong collaborative, communication, and presentation skills, with the ability to lead meetings and work effectively in a matrixed environment and across cultural lines.
Ability to prepare high-quality technical documents and submissions using internal systems.
Ability to independently manage and prioritize a multi-project workload.
Proficiency with document management and regulatory information systems, Trackwise Digital, and TRS Viewer.
Strengths in proactive strategic thinking, analytical problem solving, and negotiation.

Nice To Haves

Master's or Ph.D. degree, preferably in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology.
Regulatory Affairs Certification (RAC).
Experience in CPP application filing through eCATS and 510(j)(3) reporting through nextGen portals.

Responsibilities

Support Regulatory Affairs leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products.
Support development-phase CMC regulatory strategies from early development through marketing applications, and strategies for post-approval changes to marketed products.
Determine regulatory, scientific, and technical requirements for CMC and GMP-related submissions and inquiries.
Prepare, coordinate, and review CMC and GMP-related documents for submission to regulatory authorities, ensuring compliance with regulatory requirements, company standards, and scientific and technical requirements.
Support Regulatory Affairs leads in representing CMC Regulatory Affairs at project team meetings and provide regulatory guidance and perspective to cross-functional teams with global regulatory leads.
Support preparation for health authority CMC meetings, including mock meetings and meeting planning.
Support monthly CMC GRT meetings with global cross-functional teams for assigned products.
Interact with manufacturing and quality groups, partner organizations, and other stakeholders on CMC issues.
Develop and maintain collaborative relationships with local and global functional units, manufacturing sites, Quality, Technical Operations, affiliates, external partner companies, contract manufacturers, packagers, and suppliers.
Prepare departmental job procedures.
Assess and develop ideas to optimize local and global CMC Regulatory Affairs departmental processes, improve efficiencies, and address current and future challenges.