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

Parexel; Ascoli Piceno; Remote; EUR 70,000 - 110,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate to lead post-approval CMC activities for biologics and vaccines. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance.

This role offers remote options in several European locations and focuses on variations, renewals, and market expansions, with responsibilities spanning preparation of submissions, risk mitigation, and regulatory risk escalation.

Qualifications

• Post-approval regulatory experience in pharma CMC/biologics.
• Experience with regulatory submissions for variations/renewals.
• Knowledge of biological/vaccine processes.
• Experience writing CMC sections of regulatory documents.
• Familiarity with regulatory information management systems.
• Strong collaboration across manufacturing, QA, QC, and regulatory teams.

Responsibilities

• 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.
• 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

CMC knowledge

Regulatory submissions

Team spirit

Flexibility

Accountability

Education

Life Sciences degree

Tools

Veeva Vault

Word

PowerPoint

Excel

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) ascoli piceno, marche, it