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 company's 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).

#LI-REMOTE

📌 Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based) (Italia)
🏢 Parexel
📍 Italia