Remote Senior Regulatory Affairs - CMC & Post-Approval

Parexel; Polska; Hybrid; PLN 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Remote work

Zusammenfassung

Parexel is seeking a Senior Regulatory Affairs Associate to join our global regulatory team. The role focuses on post-approval CMC activities for biological and vaccines products, with office or home-based options in Europe.

You will develop submission strategies, review changes, coordinate cross-functional submissions, and manage Regulatory Information Management systems to ensure worldwide registrations.

Qualifikationen

• University-level education in Life Sciences or equivalent by experience.
• Experience in regulatory affairs, particularly related to technical/CMC/quality within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.

Aufgaben

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control.
• Review study reports to ensure compliance with regulatory requirements.
• Coordinate submission preparation with manufacturing, supply chain, quality control and other regulatory departments.
• Write and/or review submission content to ensure alignment with regulatory requirements for variations and health authority questions.
• Manage projects within Regulatory Information Management systems and maintain worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Kenntnisse

Regulatory affairs

CMC knowledge

Quality documentation

Regulatory submissions

Ausbildung

University degree in Life Sciences

Tools

Veeva Vault

Microsoft Word

PowerPoint

Excel

Jobbeschreibung

Parexel is seeking a Senior Regulatory Affairs Associate to join our global regulatory team. The role focuses on post-approval CMC activities for biological and vaccines products, with office or home-based options in Europe.

You will develop submission strategies, review changes, coordinate cross-functional submissions, and manage Regulatory Information Management systems to ensure worldwide registrations.