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

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).

Originally posted on Himalayas

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