At Adalvo, we''re not just a company we''re a team of passionate people driven by our mission to consistently deliver high quality products and services to our partners. We are positive, we are fast, we are always on target, we are Adalvo !
We are looking for an enthusiastic Launch Manager to join our dynamic Adalvo team. This position offers an opportunity to well suited candidates to join a growing, fast paced energetic environment and culture.
SUMMARY OF POSITION
The Launch Manager leads crossfunctional teams to plan, coordinate, and execute the successful commercialization of new products for B2B (BusinesstoBusiness) customers. This individual ensures launches meet regulatory, quality, and timeline requirements while also maximizing commercial potential. They serve as the primary point of contact for internal teams to drive ontime, inscope, and onbudget launch delivery, while overseeing the launch process with contract manufacturing organizations (CMOs).
ORGANIZATION STRUCTURE
This role reports directly to the Head of Launch Management and collaborates closely with cross functional stakeholders, including Regulatory Affairs, Quality, Supply Chain, Tech Transfer, IP and Commercial teams, as well as CMOs.
RESPONSIBILITIES
Primary responsibilities of this role include the following:
1. Launch Planning Coordination
2. Develop and maintain comprehensive launch project plans (including milestone tracking, critical paths, risk assessments, and mitigation strategies) for new products.
3. Ensure the alignment of regulatory, quality, supply chain, commercial, and business development activities with the target launch schedule.
4. Facilitate crossfunctional kickoff meetings, project reviews, and launch readiness checkpoints.
5. Project Stakeholder Management
6. Serve as the main launch point of contact for internal departments.
7. Proactively identify, communicate, and resolve project bottlenecks or crossfunctional conflicts to keep the launch on track.
8. Coordinate with Commercial and Business Development teams to ensure B2B customer requirements (timelines, volumes, packaging specifications, commercial forecasts) are fully integrated into the launch plan.
9. Regulatory Quality Alignment
10. Understand and incorporate regulatory milestones (e.g., MA s/ANDA approval, labeling requirements, postapproval commitments) into launch timelines.
11. Work closely with Quality teams to validate packaging, labeling, and product release processes, ensuring compliance with cGMP and relevant guidelines (FDA, EMA, etc.).
12. Collaborate on risk management strategies (change controls, deviation management, CAPA) that may arise during product launches.
13. Supply Chain Operations
14. Partner with Supply Chain/Operations to secure raw materials, packaging components, and p