Manager – Submissions Management (CMC)

Role: Manager – Submissions Management (CMC+QA)Location: Remote Type: Contract (B2B) Role Summary:We are seeking an experienced Manager – Submissions Management to lead a team responsible for global regulatory submission activities, including geographic expansions, variations, lifecycle management (LCM), and related regulatory operations.The role requires strong experience in regulatory submissions management, with exposure to CMC and Quality Assurance (QA) preferred. The successful candidate will be responsible for end-to-end planning and execution of regulatory activities across multiple regions and health authorities, while ensuring compliance with applicable regulatory requirements, quality standards, and organizational processes. Key ResponsibilitiesLead and manage a team responsible for global regulatory submissions, geographic expansions, variations, renewals, and lifecycle management activities.Plan and execute regulatory variations and other submissions for EMA, FDA, and applicable global health authorities, in accordance with regional and country-specific requirements.Provide end-to-end regulatory, quality, and operational support for product lifecycle activities involving biologic and small-molecule products.Develop, review, and maintain high-quality global regulatory documentation in support of submissions and lifecycle activities.Support the development and implementation of global CMC regulatory strategies aligned with evolving regulatory requirements and product lifecycle needs.Provide regulatory support for manufacturing site transfers and technology transfer activities, including review of relevant documentation and preparation of transfer-related regulatory strategies.Coordinate reviews of technology transfer documentation and associated pre-work required for manufacturing site transfers.Assess existing non-CMC documentation for suitability in site-transfer activities and coordinate required updates.Identify requirements for Module 1 and other region-specific documentation, coordinate document ownership, and ensure timely completion and review.Participate in regulatory submission strategy discussions and provide regulatory input to support effective decision-making.Proactively identify and mitigate regulatory and quality risks associated with site transfers and other lifecycle activities.Support contingency planning and participate in pre-dispatch and post-publishing reviews to ensure submission quality and completeness.Coordinate proactively with internal stakeholders, manufacturing sites, suppliers, and cross-functional teams to ensure timely delivery of submission activities.Ensure accurate and timely maintenance of regulatory, quality, and submission-related databases and trackers.Ensure all activities are performed in accordance with applicable Regulatory Affairs, Quality, and organizational SOPs and procedures.Take accountability for submission planning, execution, tracking, issue resolution, and delivery against agreed timelines.Deliver agreed SLAs, project milestones, reporting requirements, and KPIs.Support internal governance, control processes, performance reporting, and continuous improvement initiatives.Plan projects by understanding business and regulatory requirements, allocating appropriate resources, monitoring deliverables, and providing timely solutions to emerging issues.Demonstrate effective stakeholder management and maintain strong working relationships across regulatory, CMC, QA, manufacturing, supply chain, and other relevant functions. Leadership & Stakeholder ManagementProvide effective leadership, coaching, and direction to the submissions management team.Establish clear priorities, allocate resources effectively, and ensure delivery against agreed timelines and quality standards.Manage multiple projects and competing priorities in a dynamic regulatory environment.Communicate complex regulatory and project-related issues in a clear, concise, and logical manner.Demonstrate strong written, verbal, listening, influencing, and interpersonal communication skills.Foster effective collaboration across geographically dispersed and cross-functional teams.Proactively escalate risks, issues, and dependencies and drive them toward resolution. Preferred Experience & QualificationsRelevant degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Regulatory Affairs, or a related discipline.Significant experience in Regulatory Affairs and submissions management, preferably within the pharmaceutical or biotechnology industry.Experience managing global regulatory submissions and lifecycle management activities.Strong understanding of CMC regulatory requirements; hands-on CMC experience is preferred.Experience or exposure to Quality Assurance and quality management processes is preferred.Experience with variations, renewals, geographic expansions, site transfers, and other lifecycle activities.Working knowledge of regulatory requirements applicable to EMA, FDA, and other major global health authorities.Experience coordinating cross-functional teams and managing complex regulatory projects.Strong project management, organizational, analytical, and problem-solving skills.Demonstrated ability to manage timelines, priorities, risks, and stakeholder expectations.Strong attention to detail and commitment to regulatory compliance and submission quality.Excellent written and verbal communication skills. Key CompetenciesRegulatory Submissions ManagementCMC Regulatory AffairsLifecycle ManagementRegulatory StrategyQuality & ComplianceProject & Team ManagementStakeholder ManagementRisk Identification & MitigationCross-functional CollaborationProblem Solving & Decision MakingCommunication & Leadership