CMC Regulatory Lead – Biologics & Vaccines (Remote)

Parexel; Vicenza; Remote; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Remote work options

Flexible hours

Job summary

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.

Responsibilities

• 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).

Skills

Regulatory affairs

CMC knowledge

Biologics

Vaccine processes

Technical writing

Veeva Vault

Teamwork

Adaptability

Submissions

MS Word

PowerPoint

Excel

Education

Life sciences degree

Tools

MS Word

PowerPoint

Excel

Veeva Vault

Job description

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/