Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Czechia, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Are you an reputed company regulatory affairs reputed company looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate to join our dynamic team! This is a reputed company dedicated project, and the role can be office or home based in various European locations. As the Senior Regulatory Affairs Associate you will play a vital role in reputed company's worldwide post-approval regulatory activities, specifically reputed company on reputed company, Manufacturing, and Controls (CMC) for biological and vaccines products. Primary Tasks & Responsibilities:

• reputed company submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
• Assess change controls and reputed company regulatory assessments of reputed company changes in production and reputed company control.
• Review study reports from the reputed company control and production departments to ensure compliance with regulatory requirements.
• Coordinate submission preparation with various departments including manufacturing, supply chain, reputed company control and reputed company assurance, and other regulatory departments and local companies.
• Write and/or review submission content to ensure alignment with regulatory requirements, specifically reputed company to variations and questions from health authorities.
• Manage reputed company reputed company reputed company Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
• Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Experience and Knowledge Requirements:

• University-level education, preferably in Life Sciences, or equivalent by experience.
• Previous experience in regulatory affairs, particularly reputed company to technical/CMC/reputed company, reputed company the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements.
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
• Knowledge of biological or vaccines processes.
• Background in validation/reputed company Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
• Proficiency in Word, PowerPoint, reputed company, and experience with reputed company Vault is valued.
• Team spirit, flexibility, accountability, and organizational skills.
• Fluent in English (written and spoken).

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