Regulatory Manager - CMC biologics (various European locations)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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, PowerPoint, 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.