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

Parexel; Catania; A distancia; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

Parexel in Italy (Catania area) is seeking a Senior Regulatory Affairs Associate to drive post-approval regulatory activities focused on CMC for biologics and vaccines. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance.

Responsibilities include developing post-approval CMC submission strategies, assessing regulatory impact of quality changes, coordinating submissions, and writing or reviewing content for health

Formación

• University-level education in Life Sciences or equivalent by experience.
• Experience in pharma regulatory affairs focused on CMC/quality.
• Strong understanding of post-approval regulatory requirements.
• Experience writing CMC sections of regulatory documents.
• Knowledge of biological or vaccine processes.
• Experience with regulatory submissions for variations/renewals.

Responsabilidades

• 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, escape, and mitigate regulatory risks.
• Prepare regulatory documentation for registration files or variations (CMC/technical).

Conocimientos

CMC knowledge

Post-approval regulatory requirements

Regulatory submissions

Regulatory risk mitigation

Documentation writing

Teamwork

Adaptability

Accountability

Biological/vaccine processes

Validation principles

Educación

University-level Life Sciences or equivalent

Herramientas

Veeva Vault

Microsoft Word

Microsoft Excel

PowerPoint

Descripción del empleo

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, escape, 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) catania, sicilia, it