Hybrid Senior Global CMC Development – Lifecycle Manager

at Karo Healthcare

• Job title: Senior Global CMC Development – Lifecycle Manager
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Stockholm, Sweden

About the role

• Senior Global CMC Development & Lifecycle Manager at Karo Healthcare, overseeing CMC lifecycle and regulatory compliance for pharmaceutical products. Leading compliance efforts and strategies in a cross-functional team.

Responsibilities

• Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes.
• Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products.
• Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals.
• Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements.
• Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems.
• Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures.
• Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products.
• Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes.
• Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities.
• Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required.
• Provide CMC oversight and regulatory alignment during process validation, scale-up, and technology transfer activities to ensure smooth transition from development to commercial manufacturing.
• Coordinate activities with subsidiaries, external partners, and consultants across relevant markets to support aligned execution of CMC lifecycle, manufacturing, and regulatory objectives.
• Lead the preparation of CMC responses to Health Authority questions in collaboration with internal stakeholders and CMOs.
• Take the role of Regulatory CMC lifecycle project lead when appropriate, including the identification and management of technical and regulatory risks, prioritisation of activities, and tracking of key milestones.
• Proactively identify and mitigate technical and regulatory CMC risks to prevent approval delays, compliance exposure, or supply disruptions.
• Define CMC documentation requirements and timelines for variations and lifecycle changes and align with Regulatory Operations during submission planning and kick-off activities.
• Contribute to the development, maintenance, and continuous improvement of SOPs, work instructions, and related processes supporting CMC lifecycle, manufacturing, and regulatory activities.

Requirements

• University degree in Life Sciences.
• Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products.
• Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes.
• Extensive experience in variation management, including the development and execution of regulatory and CMC strategies.
• Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage.
• Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products.
• Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance.
• Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models.
• Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners.
• Experience interacting with regulatory authorities and maintaining effective professional relationships.
• Familiarity with relevant regulatory databases and compendial information sources.
• Experience with regulatory information and document management systems (e.g. Veeva RIM) is an advantage.
• Fluent in English; additional languages are an asset.

Benefits

• Opportunity to create, grow, and encourage
• Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
• Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
• Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
• Very positive work environment in a dynamic, international, and motivated team
• Start-up spirit while being a part of the large international organization with strong values