Regulatory CMC Manager Cell and Gene Therapy Updated: TodayLocation: Bogota, DC, ColombiaJob ID: -OTHLOC-7352-2DR Description Regulatory CMC Manager Cell and Gene Therapy Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and shape the solutions we deliver. As part of our team, you will collaborate with passionate problem solvers to help our customers achieve their goals in a fast‑moving environment. Job Responsibilities Reviews CMC sections of regulatory submissions and responds to regulatory agencies. Contributes to the development of global regulatory CMC strategies for commercial products. Works with regulatory colleagues on the development of global regulatory CMC strategies and submissions. Provides regulatory CMC guidance to cross‑functional teams and key stakeholders. Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations. Required Education Level & Experience Strong interpersonal skills to exchange complex information and guide others. Proficiency in regulatory (FDA, EMA, Health Canada, and ICH) guidelines. Experience in the preparation, including writing, of CMC submissions. Strategic thinking and strong problem‑solving skills. Ability to collaborate and communicate in an open, clear, and consistent manner. Strong sense of planning and prioritization, and ability to work with all levels of management. Sound knowledge of cGMP, FDA, EMA, ICH. Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics, or Medical Devices, or another related life‑science field. Summary CMC expertise in small molecule and gene therapy support to the Regulatory team with global expansion across multiple markets. Veeva RIM authoring is required. Additional Information Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education may be considered. This description does not create an employment contract. The Company complies with all applicable legislation, including the EU Equality Directive, the Americans with Disabilities Act and provides reasonable accommodations when appropriate. #J-18808-Ljbffr