Senior Regulatory Affairs Associate – CMC Biologics, Vaccines

This is a fully remote position, open to applicants in Poland.

📋 Description

• Formulate strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reporting.

• Evaluate change controls and deliver regulatory evaluations of quality modifications in production and quality control.

• Examine study reports from the quality control and production teams to verify adherence to regulatory standards.

• Facilitate the preparation of submissions by collaborating with various departments, including manufacturing, supply chain, quality control, quality assurance, and other regulatory teams and local entities.

• Draft and/or review submission materials to ensure conformity with regulatory standards, particularly concerning variations and inquiries from health authorities.

• Oversee projects within all Regulatory Information Management systems, ensuring the upkeep of global submissions.

• Recognize, escalate, and mitigate risks linked to regulatory processes and activities.

⛳️ Requirements

• Bachelor's degree, preferably in Life Sciences, or equivalent experience.

• Prior experience in regulatory affairs, especially concerning technical/CMC/quality aspects within the pharmaceutical sector.

• Comprehensive understanding of CMC and post-approval regulatory requirements.

• Experience in drafting CMC (technical) segments of regulatory documents, such as registration files or variations.

• Knowledge of biological or vaccine processes.

• Background in validation, Quality Assurance, or production within the pharmaceutical industry, with experience in preparing regulatory documentation.

• Familiarity with qualification and validation principles.

• Proficient in Word, PowerPoint, Excel, and familiarity with Veeva Vault is preferred.

• Strong team spirit, adaptability, accountability, and organizational capabilities.

• Proficient in English (both written and spoken).

🏝️ Benefits

• Health insurance

• Professional development