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

Location: REMOTE, Italy, Remote, Croatia, Czechia, Hungary, Lithuania, Poland, Warsaw, Mazovia, Poland, Romania, Belgrade, Central Serbia, Serbia, Serbia

Employment Type: Remote

Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented Senior Regulatory Affairs Associate to join our dynamic team! This is a client 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 our companys worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological and vaccines products.

Primary Tasks & Responsibilities:

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.

• Assess change controls and provide regulatory assessments of quality changes in production and quality control.

• Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.

• Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.

• Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.

• Manage projects within all 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 related to technical/CMC/quality, within 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/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.

• Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.

• Team spirit, flexibility, accountability, and organizational skills.

• Fluent in English (written and spoken).

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