Regulatory Affairs Consultant - CMC Biologics / Plasma Products

Parexel•Southport, NC

8d•Remote

About The Position

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.

Requirements

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
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
Strong communication, organization, and problem-solving skills

Nice To Haves

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

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