Overview
Are you an experienced regulatory affairs professional looking for a new opportunity? We are currently seeking a talented 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 Regulatory Affairs Consultant 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.
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).
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