Senior Regulatory Affairs Associate – CMC Biologics, Vaccines

Parexel

Senior Regulatory Affairs Associate focusing on CMC activities and submissions for biopharmaceuticals. Working remotely from various European locations with a client dedicated project.

Posted 7/15/2026full-timeRemote • 🇵🇱 PolandSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs with a strong focus on CMC and post-approval requirements in the pharmaceutical industry. Proficient in writing technical sections of regulatory documents and managing submissions across various departments.

Highest-signal resume keywords

Regulatory Affairs ExperienceCMC Documentation WritingQuality Assurance KnowledgeProject Management in Regulatory SystemsFluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Requirements UnderstandingCMC KnowledgeTechnical WritingChange Control AssessmentRisk Mitigation

Soft Skills

Team SpiritFlexibilityAccountabilityOrganizational Skills

Tools & Technologies

Veeva VaultMicrosoft WordMicrosoft PowerPointMicrosoft Excel

Industry Keywords

Pharmaceutical IndustryPost-Approval ActivitiesQuality ControlValidation PrinciplesBiological Processes

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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.
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Requirements

What you’ll need

University-level education, preferably in Life Sciences, or equivalent by experience.
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
Strong understanding of CMC and post-approval regulatory requirements.
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
Knowledge of biological or vaccines processes.
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation.
Understanding of qualification/validation principles.
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
Team spirit, flexibility, accountability, and organizational skills.
Fluent in English (written and spoken).

Benefits

Comp & perks

Health insurance
Professional development