Project manager

Cosmo is an innovative company focused on medical technologies (Med Tech), active in the development of solutions based on artificial intelligence, dermatology, gastrointestinal diseases, and CDMO services. We collaborate with global partners to improve the quality of care and patients’ lives. Our mission is to build trust in health through scientific and technological innovation.

The Project Manager will provide comprehensive leadership, oversight, and execution support for a late-stage pharmaceutical development program entering FDA and EMA registration. The role requires previous exposure to drug development, clinical operations, and regulatory, as well as the ability to coordinate complex activities across internal and external scientific, operational and business teams. Reporting directly to the CSO, and interacting with the Company’s senior management members, the Project Manager ensures that program deliverables are achieved on schedule and to the highest quality standards.

Key Responsibilities Project Management & Operational Execution Lead planning, execution, and tracking of program activities supporting the regulatory submissions (NDA/MAA) of a late-stage pharmaceutical development program, including: Define project scope, goals and deliverables. Develop detailed project plans, schedules, budgets, and tracking tools. Monitor project progress and adjust plans. Manage scope, risk, resources, budgets, and deliverables across multiple functions. Communicate project status, risks, and outcomes to stakeholders Manage changes to project scope, timeline, and costs Ensure timely preparation of documents for internal governance committees and external submissions. Coordinate internal or external meetings, managing agenda, meeting minutes and action items. Cross-Functional Coordination Liaises with core internal and external functions involved in the project, ensuring coordination, efficient communication, and coherent program execution:

Facilitate structured team meetings with clear agendas, action items, decision logs, and documented follow-up. Serve as the common point of contact linking scientific, operational, regulatory, and quality functions. Maintain a unified program timeline and proactively identify interdependencies, gaps, and risks across functions. Will help coordinate the activities of following functions:

Clinical Operations and Development

Track progress of ongoing activities (e.g., statistical analyses, CSR preparation) and ensure alignment with regulatory submission timelines. Track review cycles for clinical documents, including protocols, CSRs, SAPs, and clinical modules for the submission dossier. Nonclinical Function

Collaborate with Nonclinical team scientists to manage timelines for nonclinical study reports and integration of nonclinical data into Module 4 for the submission dossier. Support nonclinical team in coordination of any bridging or additional studies requested by regulatory authorities during the review process. Pharmaceutical & Analytical Development

Collaborate with CMC and Analytical Development teams in ensuring timely completion of formulation development, analytical method validation, comparability assessments, and stability program updates. Track progress toward critical CMC deliverables, including specifications, control strategies, stability studies, manufacturing documents (e.g., PV protocols and reports, executed MBR), and analytical documentation required for Module 3. Coordinate cross-functional reviews of CMC data packages and ensure alignment with Quality and Regulatory prior to submission. Regulatory Affairs

Collaborate with the Regulatory Affairs department and external CRO(s) to keep track of submission plans, regulatory strategies, and content timelines for FDA and EMA registration. Tracks the preparation of briefing documents, meeting packages, submission modules, and responses to regulatory queries, ensuring all functional contributors are aligned with regulatory expectations and submission milestones. In collaboration with the Regulatory Affairs department and external CRO(s), oversee collection, QC, and integration of cross-functional content (e.g., reports, documents, certificates, etc.) for Modules 1–5. Manufacturing / CMC Operations

Coordinate with internal Manufacturing and research and development team to track production campaigns, process validation activities, batch release, and supply-chain readiness for both clinical and commercial phases. Track API and finished product facility inspections. Governance, Reporting & Communication Provide regular status updates, issue summaries, and decision requests to senior leadership. Prepare materials for executive reviews and Board-level updates. Maintain documentation and communication channels in compliance with quality standards. Qualifications Required Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry and Technology, Chemistry, Biology, Biochemistry, or related discipline. >5 years of project management experience in the pharmaceutical/biotech industry. Previous knowledge of Gx P, ICH guidelines, and drug development pathways. Demonstrated ability to manage cross-functional teams and complex timelines. Demonstrated excellent proficiency in English, both written and oral. Preferred Advanced scientific or technical degree (MS, Pharm D, Ph D, MBA). Direct experience with registration-phase programs and FDA/EMA submissions. PMP or equivalent PM certification. Experience with CRO management and global teams. Competencies Strong leadership and facilitation skills. Excellent organizational, analytical, and problem-solving capabilities. Ability to work effectively in a dynamic, fast-paced, high-growth environment. High integrity and commitment to quality and compliance. We are looking for an independent freelance consultant for a project-based engagement.

Equal Opportunity Statement: We support equal opportunities, without any discrimination; The research complies with Legislative Decree 198/2006