Hiring: Senior Manager, Regulatory Affairs CMC Company: Cytokinetics Location: Greater Philadelphia Job Posted Time: 2026-09-17 01:57:13 Target Skills & Keywords : GDPR, Quality Assurance, R About the job Experience: •2-3 years in Regulatory Affairs-CMC •25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. •5+ years of industry experience in pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related, with 2-3 years in Regulatory Affairs-CMC •Over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Required Skills: •Partner cross-functionally with Regulatory Affairs, Technical Operations (drug substance, drug product, and analytical/QC subject matter experts), Supply Chain, and/or Quality Assurance to execute on regulatory submission plans based on an existing strategy, as well as identifying and implementing refinements to better support the execution process. •Serve as a technical regulatory-focused resource for colleagues, mainly supporting commercial/post-approval activities. Qualifications: •Regulatory professional with 5+ years of industry experience in pharmaceutical, biotechnology or related industry in CMC, Regulatory, Quality, R&D, and Manufacturing or related, with 2-3 years in Regulatory Affairs-CMC •Bachelor’s degree or equivalent in a related discipline. Science or pharmacist major is preferred. An advanced degree in a related discipline is preferred. •Operational familiarity with global regulatory guidelines and requirements specific to the CMC development and commercialization of small molecules. Ability to interpret global regulations and guidance •Understanding of the U.S. and EU regulations and expectations for pharmaceutical products, standards for quality, data requirements and knowledge of the regulatory review and approval process •Strong familiarity with typical regulatory submission processes and systems (e.g., submission content plans, timelines, eCTD submissions (Module 2.3 and 3), VEEVA – RIM/EDMS, change control impact assessments) •Understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) •Outstanding interpersonal and communication (written and verbal) skills •Demonstrated capacity to influence, facilitate issue resolution, and manage conflicts is a plus. Compensation: •$177,300 - $206,850 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!