Remote, COL
4 days ago
Reg Affairs Spec
**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. Essential Functions and Other Job Information: Coordinates and manages client deliverables supporting regulatory compliance.  Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.  Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.  Assists in business development and pricing of projects for the department.  Evaluates client needs in relationship to overall project timelines, quality and delivery.  Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed. **Qualifications:** **Education and Experience:** Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). **Working Conditions and Environment:**  Work is performed in an office environment with exposure to electrical office equipment.  Occasional drives to site locations with occasional travel both domestic and international 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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