At a Glance
- Tasks: Develop and manage regulatory strategies for vaccines and biological products.
- Company: Join a dynamic team in a leading pharmaceutical company.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and career advancement.
- Why this job: Make a real impact in global health by ensuring compliance in vaccine production.
- Qualifications: Experience in regulatory affairs and strong understanding of CMC requirements.
The predicted salary is between 50000 - 70000 £ per year.
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 vaccines or 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, elevate, 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 vaccines or biological 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).
Regulatory Affairs Consultant - CMC vax/bio (home or office based) employer: Parexel International
At Parexel International, we pride ourselves on being an exceptional employer, offering a collaborative and innovative work culture that empowers our employees to excel in their roles. With a strong focus on professional development, we provide ample opportunities for growth and advancement within the clinical research field, particularly in the UK and Germany, where our teams are dedicated to making a meaningful impact on patient care through cutting-edge clinical trials.
