Senior Regulatory Affairs Consultant – CMC Biologics

We work with focus, agility, and shared purpose – moving 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®.

About the Role

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.

Key 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

Candidate Profile

You'll thrive in this role if you bring:

Strengths in strategic thinking, regulatory analysis, and problem-solving

Experience working in pharmaceutical development, regulatory affairs, or a highly regulated environment

The ability to collaborate across teams and communicate clearly with manufacturing, quality, and regulatory stakeholders

A quality-focused mindset and strong attention to detail in regulatory documentation

Comfort working with regulatory information systems, document management platforms, and Microsoft Office applications

Required Qualifications

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)

Preferred Qualifications

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

Benefits and Compensation

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.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

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.

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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.