Senior Regulatory Affairs Associate – CMC Biologics/Vaccines

📋 Description

• Formulate strategies and plans for submissions related to post-approval CMC activities, including variations, renewals, market expansions, and annual reports.

• Evaluate change controls and deliver regulatory assessments concerning quality changes in production and quality control processes.

• Examine study reports from the quality control and production teams to ensure adherence to regulatory mandates.

• Oversee the preparation of submissions in collaboration with multiple departments such as manufacturing, supply chain, quality control and assurance, along with other regulatory entities and local companies.

• Draft and/or review submission materials to guarantee compliance with regulatory standards, particularly regarding variations and inquiries from health authorities.

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

• Detect, escalate, and address risks linked to regulatory processes and operations.

⛳️ Requirements

• University-level education in Life Sciences or equivalent experience.

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

• Comprehensive knowledge of CMC and post-approval regulatory standards.

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

• Familiarity with biological or vaccine processes.

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

• Understanding of qualification and validation principles.

• Proficiency in Word, PowerPoint, Excel, and familiarity with Veeva Vault is advantageous.

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

• Proficient in English (both written and spoken).

🏝️ Benefits

• Health insurance

• Professional development opportunities