Karo Healthcare is seeking a Senior Global CMC Manager (Development & Lifecycle) for our office in Stockholm. The role involves managing CMC Module 3, ensuring scientific consistency, and aligning with manufacturing processes, formulation, APIs, and control strategies. The candidate will also assess and lead regulatory CMC evaluation, review and approve regulatory CMC documentation, and lead CMC strategy development for assigned products.
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
