Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of safety into product development and lifecycle decisions; Provide clinical safety input into study design, conduct, analysis and interpretation,
Responsible for providing lead medical input and expertise to clinical development programs conducted for Therapeutic Dermatology products. Acting on the responsibility, the Head of Medical Experts, Therapeutic Dermatology, secures that clinical
Lead the nonclinical toxicology strategy across multiple research and development programs, ensuring alignment with program objectives and timelines as well as regulatory expectations; Provide scientific leadership for the design
Provide technical leadership and strategic guidance for upstream/downstream processing activities across the manufacturing network; Act as the primary point of contact for external partners, ensuring alignment with organizational goals; Lead harmonization
Own EU regulatory strategy for assigned programs from First-in-Human through pivotal development and marketing authorization; Serve as primary EU regulatory contact for cross-functional teams and provide clear, actionable regulatory guidance while
Design and execute experimental studies to develop and optimise purification processes for biologics; Evaluate and implement advanced chromatography and filtration technologies for intensified downstream processing; Develop scalable purification
You will serve as the Pediatric Regulatory Lead for assigned products and play a key role in developing and executing regulatory strategies, plans, and objectives for pediatric development programmes across the Virology, Oncology, and Inflammation
You are going to play a key global role in ensuring Quality oversight of Bio MSAT activities across internal and external manufacturing. You will drive quality excellence, support technical transfers and validation, and ensure compliance with evolving
Ensure that studies are delivered on time, within budget, and in compliance with regulatory requirements and GCP standards. Support study start-up activities (feasibility, site selection, regulatory submissions). Coordinate investigator meetings and
You will drive medical initiatives within project teams, guiding strategic direction and decision-making processes, and offer expert medical and scientific guidance, leveraging therapeutic expertise in obesity studies to inform project development
This is a senior leadership role with enterprise-wide authority and accountability for the governance, effectiveness, and continuous advancement of BioMarin’s global Supplier Quality Management framework across the external supply network for GMP/GDP
You would be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
Evaluate and develop product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical
Responsible for shaping and executing the R&D strategy within the oncology therapeutic area as well as leading strategic partnerships in the field. This role drives innovation, identifies high-impact opportunities, and steers cross-functional efforts to
Responsible for shaping and delivering the UK medical strategy, driving education, evidence generation, and engagement with healthcare professionals and key opinion leaders in the diabetes space. The role leads cross-functional collaboration
Act as a scientific and clinical expert in diabetes and CGM, ensuring the organisation remains at the forefront of emerging evidence and practice. Provide authoritative, evidence-based guidance on clinical data, device utilisation, and patient management
Develop and lead clinical biomarker strategies across Ipsen's oncology and rare disease portfolio to support critical development and portfolio decisions. Define biomarker plans to support target engagement, pharmacodynamic and mechanistic understanding,
A key focus area of the position is the preparation of regulatory CMC documentation for small molecule products during development and commercial stage, in a manner that is scientifically sound, commercially viable and in accordance with current
You will be responsible for managing the required quality activities and documentation associated with the portfolio of CMOs, ensuring that the CMOs manufacture and deliver products in compliance with Sanofi’s requirements specifications and regulations