Senior Regulatory Affairs Associate - Cmc Biologics/Vaccines (Home Or Office Based)

Parexel; Napoli; Remote; EUR 70,000 - 95,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval CMC activities for biologics and vaccines, with remote options across Europe. You will collaborate with manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance across variations, renewals, and market expansions.

The role emphasizes risk mitigation, timely regulatory assessments, and strong writing of CMC regulatory documents, while leveraging tools like Veeva Vault

Qualifications

• Post-approval regulatory experience in pharma/biologics.
• Experience with CMC and regulatory submissions.
• Strong writing and regulatory documentation skills.
• Knowledge of vaccines processes.

Responsibilities

• Develop post-approval CMC submission strategies for variations, renewals, market expansions, and annual reports.
• Assess regulatory impact of 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, elevate, and mitigate regulatory risks.
• Prepare regulatory documentation for registration files or variations (CMC/technical).

Skills

Regulatory expertise

Cross-functional collaboration

Attention to detail

Problem solving

Communication

Education

Life Sciences degree or equivalent by experience

Tools

Veeva Vault

MS Office

Job description

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.

• 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, elevate, and mitigate regulatory risks
• Prepare regulatory documentation for registration files or variations (CMC/technical)
• 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, PowerPoint, Excel; experience with Veeva Vault valued
• Team spirit
• Flexibility
• Accountability
• CMC knowledge
• Post-approval regulatory requirements
• Regulatory submissions for variations/renewals

Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based) napoli, campania, it