Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
For one of our key clients, we are looking for a Reg Affairs Manager - CMC Writer. They will be involved in the company's world-wide post approval regulatory activities related to Chemistry, Manufacturing and Controls (CMC) for biological products.
Primary Tasks & Responsibilities Prepares submission strategy and planning for post approval CMC activities (Variations, renewals, market expansions, annual reports). Assesses the change controls and provides regulatory assessments regarding the classifications of quality changes in production and quality control. Reviews study reports (process validation, stability studies, analytical method validation…) provided by quality control and production department to ensure compliance to regulatory requirements. Ensures the coordination of submission preparation with the departments involved: manufacturing, supply chain, quality control and quality assurance, but also other regulatory departments and local companies. Writes and or reviews submission content to ensure alignment with regulatory requirements (variations, questions from health authorities). Manages the projects within all GRA Regulatory Information Management systems (maintenance of the worldwide submissions). Identifies, escalates and mitigates risks related to Regulatory procedures and activities. Experience, Knowledge & Soft Skill Requirements Exhibits a very good understanding of CMC and post approval regulatory requirements. Knowledge of regulatory procedures / systems / guidances (quality control, stability, process validation, comparability studies). Excellent level of spoken and written English. Good level of spoken and written local language (depending on the location French, Italian or German). Knowledge of biological processes. Knowledge of Qualification / Validation principles. Soft Skills Manages own time to meet agreed milestones. Good communication skills, able to work in multi-cultural and multi-disciplinary environment. Writing skills. Analytical skills, with an eye for detail. Creative and critical mind. Team spirit, flexibility and accountability, and well organized. Experience Experience in regulatory affairs (related to technical/CMC/quality) in the pharmaceutical industry. Experience in writing CMC (technical) parts of regulatory documents (registration files or variations). Experience working in validation/Quality Assurance/production in the Pharmaceutical industry, with experience of preparing regulatory documentation. Education, Methodology & Certification Requirements University level (Life Sciences background is preferred) or equivalent by experience. Word, PowerPoint, Excel, experience with Veeva Vault is valued. Language Proficiency Requirements: English Fluent, French, German or Italian depending on location. What we offer: At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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