Reg Affairs Manager - CMC Writer (Biologics, LCM) - FSP

at  Thermo Fisher Scientific

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.

EXPERIENCE, KNOWLEDGE & SOFT SKILL REQUIREMENTS KNOWLEDGE/SKILLS:

• 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

• 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