[Hiring] Regulatory Affairs Consultant, CMC – Biologics @Parexel

Role Description

We are seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. 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.
• Supporting monthly global CMC GRT meetings.

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.

Qualifications

• Strengths in proactive strategic thinking, analytical problem solving, and negotiation.
• Experience working in the pharmaceutical industry within a regulated environment.
• Strong collaborative, communication, and presentation skills.
• An operationally minded approach, with the ability to prepare high-quality technical documents and submissions.
• The ability to independently manage and prioritize a multi-project workload.
• Proficiency with document management and regulatory information systems, Trackwise Digital, and TRS Viewer.

Requirements

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.
• 4-6 years of CMC experience in the pharmaceutical industry.
• 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.
• Comprehensive knowledge and experience preparing CMC (Quality) sections for investigational and marketed product submissions.
• Comprehensive understanding of the global regulatory environment.
• Demonstrated experience with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Strong analytical, problem-solving, organizational, and negotiation skills.

Preferred Qualifications

• 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.

Benefits

• Health, Vision & Dental Insurance.
• Tuition Reimbursement.
• Vacation/Holiday/Sick Time.
• Flexible Spending & Health Savings Accounts.
• Work/Life Balance.
• 401(k) with Company match.
• Pet Insurance.

For a complete list of benefits, please visit www.parexel.com/us-benefits .

Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.