You lead the site Quality organization and serve as the key authority for GMP compliance and quality strategy. In this executive leadership role, you shape the site’s quality culture while enabling the successful delivery of innovative therapies,
You will play a key part in driving operational excellence, ensuring compliance, and enabling seamless execution of strategic initiatives - from managing external events and vendor relationships to supporting budgeting processes and global collaboration.
You will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission
This key role will be responsible for ensuring the development and delivery of science-based, solution-oriented, and internally aligned regulatory CMC strategies for the program(s) under his/her accountability. Create high quality compliant CMC
Responsible for leading and coordinating operational activities supporting clinical stage development programs within CNS and rare disease indications, ensuring alignment across clinical supply, external manufacturing, quality coordination and vendor
They will lead and develop the hematology medical team, setting direction and fostering a culture of medical excellence, defining and implementing medical affairs therapeutic area (TA) strategy for hematology, aligned with affiliate and global priorities.
Lead formulation and process development activities from early development through scale-up, validation, and technology transfer. Independently conduct and/or oversee literature, patent, and regulatory research for RLDs, APIs, excipients, and
Provide leadership for strategic site initiatives, and represent site SLT quality in local cross-functional teams representing site quality. Ensure overall compliance to cGMP during manufacturing, testing and distribution of drug products meeting Sandoz
Accountable and responsible for creating innovative, evidence-based, and patient-centered delivery strategies and solutions for Dermatology trials or studies, addressing the specific needs and challenges of each customer. In partnership with
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle. Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority
The successful candidate will manage a team of Formulation Development Scientists, ensuring the efficient delivery of high‑quality pharmaceutical development projects. This role is accountable for managing project portfolios to agreed timelines and
Lead comprehensive post-marketing surveillance activities including proactive monitoring, adverse event trend analysis, signal detection, and signal management for assigned veterinary products, ensuring compliance with global regulatory standards.
Anticipates scientific and technological developments in the field of microbial DSP and drives the implementation of innovative technologies. Ensures high-quality documentation, including experimental plans, reports, risk assessments and technical
Establish and Maintain collaborative relationships with CMO/CDMO manufacturing organization to ensure successful product manufacturing, process development, and scale-up activities. Assess the performance of external manufacturing partners, identify
You will contribute to multi-disciplinary drug development managing and providing an integrated understanding of pharmacokinetics/pharmacodynamics (PK/PD), DMPK properties, and drug interaction (DDI) including model based predictive studies. Manages
You will provide expert QA leadership across Internal & External Bio MSAT activities to support manufacturing, troubleshooting, and decision‑making; You will oversee and guide complex investigations, root‑cause analysis, and CAPA implementation to
This role will combine strategic scientific leadership, hands-on experimental work, and coordination of interdisciplinary teams across molecular biology, cell engineering, immunooncology, AI/ML modelling and in vivo pharmacology. The selected candidate
It is expected that you will provide regulatory expertise and guidance on European/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal European/ROW regulatory strategy for
You will provide technical expertise and operational support for cleaning validation activities across pharmaceutical manufacturing processes. Your role ensures that equipment cleaning procedures are scientifically justified, compliant with global