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.

　　We are currently hiring Reg Affairs Manager - Global Labelling Operations (FSP)

　　Purpose of the position:

　　Leads global labeling operation of products in early development and products in drug labeling life cycle for one of our key clients.

　　Key Accountabilities/Responsibilities:

　　Act as owner for specific labeling business processes and assume role of documentation subject matter expertSupport regulatory team to manage labeling document in regulatory databaseSupport global regulatory strategists to define global labeling implementation planOrganize global labeling committee meetings and ensure archiving of minutes in partnership with global labeling strategistsSupport US affiliate or local partners in translations, SPL, mock-ups/artwork development/review and change controlSupport global regulatory strategists to continuously ensure worldwide labeling compliance between CCDS and local PIs during product life cycleLead labeling data management in regulatory database (Regulatory information management system):Enter and maintain labeling-related dataMonitor labeling End to End process in regulatory database and ensure PV inspection readiness providing regular reports as required for management review, audits, inspections or any other specific query.Develop and maintain ways of working and training materials and support database users

　　Desired Skills and Experience:

　　Prior experience in biotechnology, medical devices, combined productsPrior experience in quality and/or regulatory affairs environmentUnderstanding of clinical development, Pharmacovigilance, Regulatory, Quality and Supply Chain aspects of labeling and impact of non-complianceStrong knowledge of electronic tools such as Adobe Acrobat Pro, Regulatory information management systems, Electronic Document Management System (e.g. Veeva Vault), other tools for labeling quality control.Knowledge of eCTD dossier and labeling content.Knowledge of quality and document management.Detail oriented and well organizedGood oral and written English language skillsActive listening, understanding constraints from other disciplineCritical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached to problemsActive learning: understanding the implications of new information for both current and future problem-solving and decision-makingAnalytical skills: decision taking based on facts and figures rather than on assumptionsTeam player who seeks to help and learn from colleaguesHigh learning attitude and adaptabilityAt least Bachelor's DegreeAt least 5 years experience in global labeling operation

　　Work Environment:

　　At PPD clinical research services we hire the best, develop ourselves and each other, and recognize 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 clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

　　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.

　　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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