Regulatory Affairs Consultant - CMC Biologics / Plasma Products

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(R).

About the Role

We are seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) to join our team in a remote capacity. As a Regulatory Affairs Consultant, you will support post-approval regulatory activities that advance new treatments for patients. This position plays a key role in Chemistry, Manufacturing, and Controls (CMC) regulatory strategy, compliance oversight, and regulatory submission accuracy. You'll collaborate with cross-functional teams including manufacturing, quality, and supply chain partners, follow industry-standard processes, and contribute to regulatory operations from submission planning through approval and market expansion.

Responsibilities include developing CMC submission strategies, assessing change controls, reviewing quality documentation, and managing regulatory information systems, with opportunities to deepen your expertise in post-approval regulatory affairs and influence clinical product development outcomes.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory guidance, quality assurance, and global market compliance. With diverse teams and continuous learning opportunities, the Regulatory Affairs Consultant can explore career paths and expand skills across regulatory affairs, quality, and clinical development.

Key Responsibilities

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports

Assess change controls and provide regulatory assessments of quality changes in production and quality control processes

Review study reports and quality documentation from manufacturing and quality control departments to ensure compliance with regulatory requirements

Coordinate submission preparation with cross-functional teams including manufacturing, supply chain, quality control, quality assurance, and other regulatory departments

Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and responses to health authority questions

Manage projects within Regulatory Information Management systems, ensuring the maintenance and accuracy of worldwide submissions

Identify, escalate, and mitigate risks associated with regulatory procedures and activities across global markets

Candidate Profile

You'll thrive in this role if you bring:

Expertise in CMC regulatory strategy, post-approval regulatory processes, and quality/technical documentation

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

The ability to collaborate across teams and communicate clearly with internal stakeholders and regulatory authorities

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

Comfort working with regulatory information management systems, Word, PowerPoint, and Excel

Required Qualifications

Bachelor’s in Chemistry or a related Life Sciences field of study

5+ years of experience in regulatory affairs, particularly in technical/CMC/quality regulatory roles within the pharmaceutical industry

Strong understanding of CMC and post-approval regulatory requirements for global markets (US, EU, CA, CH, AU, CN, BR)

Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations

Previous biologics regulatory CMC experience

Knowledge of plasma product manufacturing processes and regulatory requirements is a plus

Strong communication, organization, and problem-solving skills

Preferred Qualifications

Background in validation, Quality Assurance, or production in the pharmaceutical industry with experience in preparing regulatory documentation

Understanding of qualification and validation principles

Experience with Veeva Vault or other regulatory information management systems

Fluency in English and additional languages

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.

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 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.

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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