Remote Senior Regulatory Affairs Associate - CMC (Vaccines)

Parexel International

Town of Italy (NY)

Hybrid

USD 110,000 - 150,000

Full time

14 days+

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Job summary

Parexel International seeks a Senior Regulatory Affairs Associate to join our global post-approval team, focusing on CMC for biological and vaccines products. Office or home-based in Europe; remote work options available.

You will develop submission strategies, assess change controls, and coordinate submissions across manufacturing, QA, QA, and local affiliates. Strong English, CMC knowledge, and regulatory writing experience are essential for success.

Qualifications

University-level education, Life Sciences preferred or equivalent by experience.
Experience in regulatory affairs, especially technical/CMC/quality in pharma.
Strong understanding of CMC and post-approval regulatory requirements.
Experience writing CMC sections of regulatory documents (registration files or variations).
Knowledge of biological or vaccines processes.
Background in validation/QA/production in pharma; experience preparing regulatory documentation.
Proficiency with Word, PowerPoint, Excel; experience with Veeva Vault.
Team-oriented, flexible, accountable, and well-organized.
Fluent in English (written and spoken).

Responsibilities

Develop submission strategies for post-approval CMC activities (variations, renewals, market expansions, annual reports).
Assess change controls and regulatory assessments of quality changes in production and QA.
Review study reports to ensure regulatory compliance.
Coordinate submission prep with manufacturing, supply chain, quality control/assurance and other regulatory departments.
Write/review submission content to align with regulatory requirements (CMC).
Manage projects within Regulatory Information Management systems and worldwide submissions.
Identify, escalate, and mitigate regulatory risks.