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As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Job Responsibility
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
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)
What we offer
flexibility of working remotely
supportive and dynamic team
challenging assignments
mentorship from experienced regulatory professionals