Regulatory Affairs Consultant, CMC – Biologics

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose. We move with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.

We are seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity based. As a Regulatory Affairs Consultant, CMC
- Biologics, you will provide CMC regulatory strategy input and expertise for investigational, new, and marketed biologic and small molecule drug products. Your work will help ensure these products are developed and maintained in compliance with global regulatory requirements and guidance, with primary responsibility for the US, EU, and Canada to support smooth, timely approvals and continued marketing.

This position plays a key role in regulatory compliance, the preparation of CMC and GMP documentation for health authority submissions, and support for health authority CMC meetings. You will collaborate with Regulatory Affairs leads and cross-functional partners across manufacturing, quality, Technical Operations, affiliates, and external partners, and contribute to regulatory strategy from early development through post-approval changes. Responsibilities include preparing and reviewing CMC and GMP-related submissions, representing CMC Regulatory Affairs in project team meetings, and supporting monthly global CMC GRT meetings, with opportunities to deepen your expertise and influence program outcomes.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic CMC regulatory input, high-quality submissions, and continuous improvement of departmental processes. Your work helps bring safe, high-quality medicines to patients, which is central to advancing clinical research. With diverse, global teams and continuous learning opportunities, you can explore career paths and expand skills across regulatory affairs and drug development.

• 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 the development of CMC regulatory strategies for development-phase products, from early development through marketing applications, and for post-approval changes to marketed products.
• Determine regulatory and 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 in project team meetings, providing regulatory guidance and perspective to cross-functional teams in conjunction with global regulatory leads.
• Support Regulatory Affairs leads in preparing 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, including CMC Regulatory Affairs, manufacturing sites, Quality, Technical Operations, affiliates, external partner companies, contract manufacturers, packagers, and suppliers.
• Prepare departmental job procedures.
• Assess and develop innovative ideas to optimize local and global CMC Regulatory Affairs departmental processes, improving efficiencies and addressing current and future challenges.

You will thrive in this role if you bring:

• Strengths in proactive strategic thinking, analytical problem solving, and negotiation
• Experience working in the pharmaceutical industry within a…