Senior Regulatory Affairs Consultant – CMC Biologics

Parexel; Madison (WI); Remote; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health Insurance

401(k) Match

Tuition Reimbursement

Paid Time Off

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics to join our team remotely. You will support regulatory strategy and compliance for drug development across investigational, new, and marketed products for a major biopharmaceutical client, ensuring GMP compliance and global submissions (FDA, EMA, Health Canada).

You will collaborate with manufacturing, quality, and project management to guide product development from early stages through post-approval, expanding expertise

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD).
• 7+ years of CMC experience with regulatory filing history.
• Knowledge of global regulatory requirements (FDA/EMA/Health Canada).
• Experience with biologics and small molecules in development and post-approval.

Responsibilities

• Develop CMC regulatory strategies for biologic and small molecule products.
• Prepare CMC (Quality) sections for IND, NDA, DMF submissions.
• Coordinate with manufacturing, quality, and project teams across regions.
• Support health authority meetings and post-approval changes.

Skills

Regulatory Strategy

CMC Experience

GMP Knowledge

Cross-Functional Collaboration

Regulatory Submissions

FDA/EMA/Health Canada

Education

Bachelor's in Pharmaceutical Sciences

PharmD

Master's/PhD (Preferred)

Tools

TrackWise

CREDO

ORIOM

TRS Viewer

Job description

About Parexel

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 – 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.

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.