Regulatory Affairs Consultant - CMC plasma products (home or office based)

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 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 and plasma products. For this role, we are looking for someone who has experience of conducting change control assessments for global markets (US, EU, CA, CH, AU, CN, and BR).

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 plasma products processes - must.

• 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).