About the company:
\nSince 1997 Monteresearch has been at the forefront of pharmaceutical R&D;, designing and optimising advanced drug-delivery technologies that go “Beyond the Standard of Care.” Today we operate a purpose-built 1,800 m² GMP-qualified site near Milan and sit within EMS (NC Group) – Brazil’s largest pharmaceutical company – giving our teams the agility of a specialised lab and the resources of a global network.\n
Our mission is to transform bold scientific concepts into market-ready therapies for unmet medical needs, with a focus on repositioning small molecules, oral peptides and oligonucleotides.
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End-to-end in-house capabilities span formulation and analytical development, IMP manufacturing, clinical supply, regulatory CMC, and pivotal trial management, allowing scientists to see their ideas progress from benchtop to first-in-human studies under one roof.
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Monteresearch is also the GMP analysis and release bridgehead to European market for EMS specialty and primary care products.
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Joining Monteresearch means collaborating in an environment that values scientific rigour, innovation and a strong sense of belonging. You will work alongside multidisciplinary experts who share a commitment to reliability, quality and patient-centric solutions, backed by the stability and growth prospects of an international group.
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If you are driven to shape the future of drug delivery and make a tangible impact on global health, we invite you to explore the opportunity below.
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About the role:
\nWe are looking for a\n
Regulatory CMC Project Manager to join our team and support the coordination and execution of regulatory activities related to CMC (Chemistry, Manufacturing and Controls).
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This role sits at the interface between technical teams and regulatory requirements, ensuring that documentation, timelines and submissions are aligned and efficiently managed.
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You will be part of a dynamic team, playing an active role in ensuring the quality and reliability of laboratory operations.
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What you will do:
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- Coordinate CMC regulatory activities across projects (EMA, Balkans, US)
- Manage timelines and ensure alignment with internal stakeholders
- Support preparation and organization of regulatory documentation
- Support and preparation of Scientific Advice
- Collaborate with cross-functional teams (analytical, quality, headquarter team, external partners) inside the company
- Ensure consistency and completeness of technical documentation through GAP analysis process
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What we are looking for:
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- Degree in Chemistry, CTF or related scientific field
- 2–5 years of experience in regulatory CMC or similar roles
- Good understanding of CMC documentation structure (CTD, IMPD; IND)
- Strong organizational and project management skills
- Ability to manage multiple activities and deadlines
- Fluent English
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What we offer
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- Salary income: 40.000 – 47.000 €
- Hybrid remote work according to company policies