Regulatory Affairs Consultant - CMC US/EU, Mature Biological products

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 Chemistry, Manufacturing, and Controls (CMC) Strategy Senior Associate / Consultant (CMC Regulatory Affairs) to join our team in a remote capacity. As a CMC Strategy Senior Associate / Consultant, you will lead and contribute to CMC regulatory strategy for biologics and vaccines, supporting patients worldwide. This position plays a key role in global product lifecycle activities, regulatory submission quality, and global regulatory compliance. You will work within a dedicated client program, partnering closely with a leading organization to drive high-impact submissions and lifecycle management activities from planning through execution. Responsibilities include shaping CMC regulatory strategies, authoring and reviewing CMC documentation, and performing dossier gap analyses, with opportunities to deepen your expertise and influence strategy and regulatory outcomes.

You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through global submissions, lifecycle management, and long-term client partnerships. This is more than a delivery role. It is an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes. You will gain global exposure across US, EU, and international regulatory landscapes, With diverse teams and continuous learning opportunities, the CMC Strategy Senior Associate / Consultant can explore career paths and expand skills across global CMC regulatory strategy.

Key Responsibilities

• Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes.
• Author and review high-quality CMC documentation (Modules 1-3) for global submissions.
• Support and lead global submissions (US, EU, and beyond) from planning through execution.
• Perform CMC dossier gap analyses and provide clear, strategic recommendations.
• Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders.
• Act as a key contributor within a dedicated client team, building strong, trusted relationships.
• Ensure submissions meet global regulatory expectations with precision and excellence.

Candidate Profile

You'll thrive in this role if you bring:

• Strengths in CMC regulatory strategy, CMC Modules 1-3 authoring and review, and dossier gap analysis
• Experience in CMC Regulatory Affairs or CMC Strategy within a regulated biopharmaceutical environment
• The ability to collaborate across teams, manage stakeholders, and communicate clearly
• A patient-focused mindset, a commitment to quality and integrity, and strong attention to detail
• Comfort working with global submission processes and regulatory documentation standards

Required Qualifications

• 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role and 5+ years of experience for a Regulatory Affairs Consultant role
• Hands-on experience with commercial biologicals and/or vaccines
• Strong knowledge of global regulatory requirements (FDA, EMA, and international markets)
• Proven experience in global submission management
• Expertise in authoring and reviewing CMC Modules 1-3 to support variations and performing gap analyses
• A collaborative mindset with strong communication and stakeholder management skills

Preferred Qualifications

• Experience with Veeva Vault (RIM/eCTD systems)

Due to the client’s location, candidates located in the eastern time zone of Canada are preferred.  Consideration, however, will be given to exceptional candidates located in other Canadian time zones provided there is flexibility to work ET hours.

Parexel offers a comprehensive benefits package to eligible employees and we offer competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

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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