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 Project 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

This role involves independently managing and coordinating pharmaceutical development projects, ensuring alignment of timelines, budgets, and deliverables across cross-functional teams and external partners. It requires proactive risk management, effective stakeholder communication, and strong organizational skills to drive project execution, reporting, and decision-making within a complex, regulated environment.

RESPONSIBILITIES

• Manage and coordinate projects, tasks, schedules, status and project reporting to stakeholders independently.
• Facilitate communication within and outside the project team.
• Facilitate problem-solving & decision-making with respect to project deliverables and meeting timelines/tasks/requests from project teams and other cross-functional departments.
• Follows up with team members to ensure timely deliverables (e.g., major milestones, cost and scope)
• Focus on proactive planning to manage risk, remove barriers and meet goals.
• Establish project plan baselines and document assumptions.
• Fully understand business cases including competitive landscape, regulatory/clinical requirements, IP landscape and other potential external factors which may derail the project.
• Prepare draft agendas, meeting minutes, presentations for project related meetings to varied stakeholders, including governance boards.
• May organize and participate in partner meetings as they relate to the position.
• Review relevant project specific documents.
• Management of Reference Drug procurement and shipment - Compiles and monitor completion of key development tasks through milestone completion, quality gates, and stage gating processes.
• Identify trends among common projects.
• Identify project budget risks and opportunities, describe the impact and adjust the budget to create acceleration opportunities for important milestones.
• Manage and reports project budget, contract milestones and spend according to established financial cycles. shall be involved in 5YP budget preparation, 3+9, 6+6 and 9+3 forecast preparation.
• Ready to travel to different CMDO/CMO/CPO across different geographies as per organizational need.

QUALIFICATIONS & REQUIREMENTS

• MS in pharmaceutical science, chemical engineering, or equivalent scientific discipline. MBA is an asset.
• At least 10 years of experience in Project Management with a track record of successfully managing pharmaceutical products from development through highly regulated registration stages to successful launches and commercialization.
• Should have thorough understanding of generic drug development cycle including 505(B2) and complex generics and various regulatory guidelines, (ICH, ANVISA, USFDA, EMA) and regulations (GMP, GCP, GLP etc.)
• Should have thorough understanding of eCTD dossier modules and various regulatory filing pathways for EU, US, CA, PMDA, LATAM etc.
• Should have knowledge of EPM / MSP software and expert in Microsoft excel and power point presentations.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and build relationships with key stakeholders.
• Demonstrated ability to work in a fast-paced, dynamic environment with a sense of urgency and the ability to prioritize effectively.

Why join us?

🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.

🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!

Please be informed that only selected candidates will be contacted.