Senior Regulatory Affairs Associate – CMC Biologics/Vaccines

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

📋 Description

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

• Evaluate change controls and deliver regulatory assessments related to quality changes in production and quality control.

• Analyze study reports generated by quality control and production departments to confirm compliance with regulatory standards.

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

• Draft and/or review submission content to ensure it meets regulatory standards, particularly concerning variations and inquiries from health authorities.

• Manage projects across all Regulatory Information Management systems, ensuring the upkeep of global submissions.

• Recognize, elevate, and mitigate risks linked to regulatory procedures and activities.

⛳️ Requirements

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

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

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

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

• Familiarity with biological or vaccine processes.

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

• Knowledge of qualification and validation principles.

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

• Possess teamwork skills, adaptability, responsibility, and strong organizational capabilities.

• Proficient in English, both written and spoken.

🏝️ Benefits

• Health insurance

• 401(k)

• Flexible work arrangements

• Professional development

• Paid time off