Regulatory Affairs Manager - CMC biologics (various European locations)
Parexel
Milan
25
Scarso
help
thumb_up Mi piace
Azienda: Parexel Milan
Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager ( Regulatory Affairs Consultant) 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 CMC Regulatory Manager, 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 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 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, Power Point, Excel, and experience with Veeva Vault is valued.
•
Team spirit, flexibility, accountability, and organizational skills.
•
Fluent in English (written and spoken). French, Italian and German would be a strong plus.
✔ Parexel