Senior Manager CMC Regulatory Affairs

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeAt Thermo Fisher Scientific Inc., 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, 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.Responsibilities Leads CMC strategy, authoring, and preparation of postapproval variations, annual reports, renewals, tender applications, and GMP submissions including responses to HA requestsPerforms global change control assessments and provide CMC requirements for variations.Align with clients (define information flow) on technical information to be provided and timelinesOversee and provide packages for internal client review and update these as neededOversee and provide finalized packages for publishing and QC published outputUpdate of internal systems (RIMS, Publishing, eDMS) or documentation as neededSupport requests for information from HAs or from partnersProvides regional lead review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects of the highest complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.Ensures quality performance for key/managed projects.Manages project budgeting/forecasting functions.Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.Collaborates with business development in pricing and securing new business by making presentations to clients and develops proposal texts and budgets in collaboration with other departments.Provides matrix/project leadership, training, and guidance to junior team members.Ensures compliance with relevant organizational and department SOPs and WPDs.Participates in launch meetings, review meetings and project team meetings. May lead departmental initiatives/project teams.General Required Skills And QualificationEducation:University degree in life sciences or related health sciences (BS/BA/MS or equivalent, PhD), a degree in Regulatory Affairs is advantageous.Experience:8+ years regulatory experience in the pharmaceutical/health care industry. 5+ years Regulatory CMC experience.Sound knowledge in life sciences with a focus on biological/vaccines/ complex small molecule/gene therapy medicinal products. Experience in plasma related products is an advantage.Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia, China, and Rest of World).Strong regulatory CMC authoring skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements. Strong knowledge in Good Manufacturing Practice or related areas.Technical SkillsMust be familiar and able to work with RIMS (e.g Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems.Microsoft Office skills.Competencies:Excellent communication, project management, planning, problem solving and presentation skillsStrong team player with a demonstrated ability to develop constructive and effective relationships with peers and managementStrong organizational and follow-up skills, as well as attention to detailAbility to work with minimal supervision based on sound technical and analytical judgment Flexibility to work in a global cross-cultural work environmentFluent in English and local languageBenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!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 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 organization but with a local feel.Our 4i Values:Integrity – Innovation – Intensity – InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!Clinical Research | Thermo Fisher ScientificOur team of colleagues in clinical research services are at the forefront of getting cures to market#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.