Regulatory Affairs Consultant – CMC, Vax/Bio

This is a fully remote position, open to applicants in Italy, +6 more countries.

📋 Description

• Formulate strategies and plans for submissions related to post-approval CMC activities, which include variations, renewals, market expansions, and annual reports.

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

• Examine study reports from the quality control and production teams to ensure regulatory compliance.

• Collaborate with manufacturing, supply chain, quality control, quality assurance, regulatory departments, and local companies to prepare submissions.

• Draft and/or review content for submissions concerning variations and inquiries from health authorities.

• Oversee projects within Regulatory Information Management systems and maintain global submissions.

• Recognize, escalate, and address risks associated with regulatory procedures and activities.

⛳️ Requirements

• A university degree, preferably in Life Sciences, or equivalent experience.

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

• Strong comprehension of CMC and post-approval regulatory obligations.

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

• Must possess knowledge of vaccines or biological processes.

• Background in validation, Quality Assurance, or production within the pharmaceutical industry, with a focus on preparing regulatory documentation.

• Understanding of qualification and validation principles.

• Proficiency in Microsoft Word, PowerPoint, and Excel.

• Familiarity with Veeva Vault is a plus.

• Fluent in English, both written and spoken.

• Demonstrated teamwork, flexibility, accountability, and strong organizational skills.

🏝️ Benefits

• Competitive salary and benefits package.

• Opportunities for professional development and career advancement.

• Supportive work environment with a focus on teamwork and collaboration.

• Access to cutting-edge technologies and resources.