Senior Regulatory Affairs Consultant – CMC Biologics

Parexel•Southport, NC

6d•Remote

About The Position

We are seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team in a remote capacity. As a Senior Regulatory Affairs Consultant – CMC Biologics, you will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for large-dedicated biopharmaceutical client partnership. This position plays a key role in ensuring products are developed and maintained in compliance with global regulatory requirements, supporting submissions to the FDA, EMA, and Health Canada. You'll collaborate with cross-functional teams including manufacturing, quality, and project management, follow industry-standard processes, and contribute to product development from early stages through post-approval. Responsibilities include developing CMC regulatory strategies, preparing regulatory submissions, and ensuring compliance with GMP and regulatory guidance, with opportunities to deepen your expertise in pharmaceutical development and influence regulatory outcomes. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through advancing biopharmaceutical development, ensuring regulatory compliance, and supporting global market access. With diverse teams and continuous learning opportunities, the CMC Regulatory Affairs Specialist can explore career paths and expand skills across regulatory affairs, quality assurance, and pharmaceutical development.

Requirements

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)
7+ years of CMC experience in the pharmaceutical industry with a demonstrated history of successful regulatory filing documentation
Comprehensive knowledge of drug development processes, pharmaceutical technology, drug manufacturing processes, and GMP requirements
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 experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada
Comprehensive understanding of the global regulatory environment
Strong analytical, problem-solving, organizational, and negotiation skills
Strong collaborative, interpersonal, communication, and presentation skills
Demonstrated ability to work independently, manage multiple projects, and prioritize in a matrixed environment
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook)

Nice To Haves

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

Responsibilities

Support regulatory leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products
Determine regulatory and scientific/technical requirements for CMC and GMP-related submissions and regulatory inquiries
Represent CMC regulatory affairs in project team meetings and provide regulatory guidance and perspective to cross-functional teams in conjunction with global regulatory leads
Prepare, coordinate, and review all CMC and GMP-related documents for submission to regulatory authorities to ensure compliance with regulatory standards, company requirements, and scientific/technical specifications
Develop CMC regulatory strategies for developmental phase products from early development through marketing applications, and support post-approval changes for marketed products
Interact with manufacturing, quality, and partner organizations to address CMC-related issues and ensure alignment across functional areas
Develop and maintain collaborative relationships with local and global functional units, manufacturing sites, contract manufacturers, and external partner companies
Support regulatory leads in preparation for health authority CMC meetings and mock meetings
Assess and develop innovative ideas to optimize CMC regulatory departmental processes and improve efficiencies
Demonstrate proficiency with required tools and systems including CREDO, ORIOM, Trackwise Digital, and TRS Viewer