Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

Overview

As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions, delivering timely regulatory assessments and risk mitigation. This role offers remote options in several European locations and partners closely with cross-functional teams to make a patient impact.

Responsabilità

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

Assess regulatory impact of quality changes in production and QC

Review study reports for regulatory compliance with requirements

Coordinate submission preparation with manufacturing, supply chain, quality control, QA, and local/regulatory teams

Write/review submission content aligned with regulatory expectations, including health authority inquiries

Manage Regulatory Information Management systems to maintain worldwide submissions

Identify, escalate, and mitigate regulatory risks

Prepare regulatory documentation for registration files or variations (CMC/technical)

Requisiti fondamentali

University-level education, preferably Life Sciences, or equivalent by experience

Experience in regulatory affairs related to technical/CMC/quality in pharma

Strong understanding of CMC and post-approval regulatory requirements

Experience writing CMC sections of regulatory documents

Knowledge of biological or vaccine processes

Background in validation/Quality Assurance/production with regulatory documentation experience

Understanding of qualification/validation principles

Proficiency with Word, Power

Point, Excel; experience with Veeva Vault valued

Team spirit

Flexibility

Accountability

CMC knowledge

Post-approval regulatory requirements

Regulatory submissions for variations/renewals