Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics)

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.

Are you ready to play a critical role in bringing life-changing biologics and vaccines to patients worldwide?

We’re looking for a CMC Strategy Senior / Regulatory Affairs Consultant who thrives in a dynamic, collaborative environment and is passionate about shaping global regulatory strategies. In this role, you’ll work within a dedicated client program, partnering closely with a leading organization to drive high-impact submissions and lifecycle management activities across both development and commercial products.

This is more than a delivery role. It’s an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes.

What You'll Do
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Lead and contribute to global CMC regulatory strategies for commercial biologics and vaccine products

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Support and drive post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitments

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Author and review high-quality CMC documentation (Modules 1-3) for global submissions

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Perform CMC dossier gap analyses and provide clear, strategic recommendations

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Lead and support global submissions (US, EU, and international markets) from planning through execution

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Partner cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders

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Assess regulatory impact of product, process, manufacturing, analytical, and control strategy changes

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Act as a key contributor within a dedicated client team, building strong, trusted relationships

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Ensure submissions meet global regulatory expectations with precision, quality, and compliance

What You'll Bring

Required Qualifications
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5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant role

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Demonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccines (required)

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Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products, including one or more of the following:
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Post-approval supplements

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Variations

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Manufacturing changes

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Process changes

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Analytical method updates

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Site transfers

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Specification changes

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Health authority commitments

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Labeling-related CMC changes

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Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets

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Proven experience supporting global submission strategy and execution

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Expertise authoring and reviewing CMC Modules

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Experience performing CMC dossier assessments and gap analyses

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Strong communication, collaboration, and stakeholder management skills

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Ability to work directly with clients and cross-functional teams in a highly matrixed environment

Preferred Qualifications
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Experience supporting both clinical development and commercial lifecycle management activities

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Experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities

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Experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems

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Advanced scientific degree (MS, PhD, PharmD, or equivalent)

Why You'll Love This Role

Dedicated Client Partnership

Build deeper relationships and drive long-term impact throu