Specialist CMC Regulatory Affairs

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeAre you ready to advance your career with a highly dynamic team? Thermo Fisher Scientific Inc. seeks a Specialist in CMC Regulatory Affairs. Join our world-class organization and help us make the world healthier, cleaner, and safer. This is your chance to be part of a team that values innovation, collaboration, and excellence!ResponsibilitiesAuthor and prepare global CMC variation submissions, annual reports and renewals, tender applications, and GMP submissionsComply strictly with client’s technical information requirements and timelinesProvide packages for internal client review, update as needed, and deliver finalized packages for publishing and QCUpdate internal systems (RIMS, Publishing, eDMS) or documentation as requiredSupport requests for information from Health Authorities or partnersWork closely with other departments, regulatory consultants, and regulatory authoritiesIdentify and acknowledge out-of-scope activities in contracts promptly and coordinate with other departments to effectively carry out contract modificationsRequired Skills And QualificationsEducationUniversity degree or equivalent experience in life sciences or related health sciences (BS/BA/MS or comparable)A Degree or equivalent experience in Regulatory Affairs is beneficialExperienceAt least 2 years of experience in the biotech or pharmaceutical sector, with a minimum of 2 years specifically in Regulatory Affairs CMCExperience in life sciences, particularly in biological, vaccines, small molecule, or gene therapy medicinal products, is beneficialProven regulatory CMC authoring skills with the ability to evaluate technical and scientific CMC information for accuracy and complianceTechnical SkillsFamiliarity with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva, Documentum), and Change Management (e.g., Trackwise) systemsProficiency in Microsoft OfficeProficienciesExcellent communication, project management, planning, and problem-solving skillsStrong great teammate with a demonstrated ability to develop constructive and effective relationships with peers and managementOutstanding organizational and follow-up skills, with strong attention to detailAbility to work independently with sound technical and analytical judgmentFlexibility to thrive in a global cross-cultural work environmentProficient in English and the local language