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

Parexel; Vicenza; À distance; EUR 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Remote work options

Flexible hours

Résumé du poste

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

Responsibilities include developing post-approval CMC submissions, assessing regulatory impact of changes, coordinating with cross-functional teams, reviewing study reports, and writing/

Qualifications

• University-level Life Sciences degree (preferably) or equivalent by experience.
• Regulatory affairs experience in pharma, focusing on CMC/technical documentation.

Responsabilités

• Develop post-approval CMC submission strategies for variations and renewals.
• Assess regulatory impact of quality changes in production and QC.
• Coordinate submission preparation with cross-functional teams.
• Write/review submission content aligned with regulatory expectations.
• Manage Regulatory Information Management systems for worldwide submissions.
• Identify, escalate and mitigate regulatory risks.
• Prepare regulatory documentation for registrations and variations (CMC/technical).

Connaissances

Regulatory affairs

CMC knowledge

Biologics

Vaccine processes

Technical writing

Veeva Vault

Teamwork

Adaptability

Submissions

MS Word

PowerPoint

Excel

Formation

Life sciences degree

Outils

MS Word

PowerPoint

Excel

Veeva Vault

Description du poste

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, escalation, 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) vicenza, veneto, it