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Title: Regulatory CMC Program ManagerLocation: Hybrid (Remote with travel as needed)Employment Type: Part-Time / Full-TimeDirect Reports: NoHourly Range: $100/hr - $150/hrCompany Overview:Founded in 2002, Enterey brings a wide range of consulting expertise in partnering with our clients in the Life Sciences Industry to help them reduce risk, operate more efficiently, and focus on what they do best - delivering safer, more effective products and treatments for their patients. We show uncompromised commitment to excellence as we deliver high-quality, tangible solutions within our areas of expertise to support our primary goal of client satisfaction. Enterey employees will directly impact the growth of company value and share in the resulting rewards.Enterey specializes in the Biotechnology, Pharmaceutical, and Medical Device industries. Position Summary:The Regulatory CMC Project Manager is a client-facing consulting role responsible for providing project management support to Regulatory Chemistry, Manufacturing, and Controls (CMC) programs for pharmaceutical, biotechnology, and/or medical device clients across the product development lifecycle.This role partners with client teams to plan, structure, and drive execution of complex CMC and regulatory initiatives that support key development milestones, including INDs/CTAs, NDAs/BLAs, MAAs, supplements, variations, and approvals. Acting as both project leader and trusted advisor, the Regulatory CMC Project Manager ensures alignment between regulatory strategy, CMC development activities, and overall program objectives.The ideal candidate brings proven Regulatory CMC expertise, excellent client communication and facilitation skills, and the ability to manage multiple engagements in fast-paced, ambiguous environments.Travel Requirements:This position may require up to 50-70% travel, based on client engagements and project needs. (May include domestic and limited international travel.)Essential Duties & Responsibilities:Establish and lead cross-functional, high-performance program teams through effective planning and execution of projectsResponsible for all project management activities including scoping, scheduling, budgeting, resourcing, and reporting as necessary to deliver program results in an efficient mannerDrive development and execution of complex, integrated plans in alignment with strategic vision and operationalizationA clear understanding of the critical pathBalance and deliver on multiple assigned program/project objectivesDemonstrate ability to recognize changing priority tasks Lead efficient, effective, and collaborative team meetingsDrive team member ownership and engagement and production of key meeting outputs that drive meaningful action and decisionWell-versed in risk management and able to develop and implement appropriate contingency and mitigation strategiesAct as the single point of contact for project informationDrive and maintain a collaborative and solution-focused communication styleSkilled in analytics and data-driven decision-making and reportingExperience with a wide variety of project management methodologiesAbility to match approach with people and project needsFocus on continual improvement and knowledge managementCollaborating with PMO Leaders to evolve current state PM practices to best-in-class program management competencies across the company.Position Requirements:Education Required:Bachelors Degree (BS/BA) in life sciences, engineering, pharmacy, chemistry, or a related disciplineEducation Preferred:Masters Degree (MS), PharmD, or advanced degree in a scientific or regulatory disciplineExperience Required:5+ years of project management experience supporting Regulatory Affairs and/or CMC activitiesExperience working in client-facing, consulting, or matrixed environmentsStrong understanding of drug development, manufacturing, and regulatory processesAbility to manage multiple concurrent projectsExcellent written and verbal communication skillsComfort working with ambiguity and adapting to new client environmentsExperience Preferred:Life sciences consulting experienceExperience supporting global regulatory submissionsFamiliarity with FDA, EMA, ICH, and global CMC regulatory expectationsPMP or equivalent project management certificationSpecialized or Technical Knowledge Licenses, Certifications needed:Proficiency with project management and collaboration tools such as MS Office, MS Project, Smartsheet, SharePoint, or similar platforms. PMP preferred but not required. This position offers a challenging and rewarding opportunity to contribute to the development and commercialization of life-saving medications.Visit