Manager and Executive jobs in Belgium (3), Bulgaria (1), Croatia (1), Czech Republic (1), Denmark (10), Finland (1), France (5), Germany (6), Hungary (1), Ireland (5), Italy (2), Multiple Countries (14), Netherlands (8), Poland (3), Portugal (1), Romania (1), Slovenia (1), Spain (6), Sweden (1), Switzerland (9) and United Kingdom (8).
This role is accountable for defining the vision, operating model, and multi-year strategy for internal QC to support Genmab’s evolving pipeline and transition to a fully integrated, commercial-stage biotechnology company. The role will shape future QC
You will 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
Currently we are seeking a highly motivated and team-oriented candidate to create, communicate and execute DMPK strategy as a project representative person within integrated discovery project teams, facilitating the identification and development of drug
Define and lead the execution of global regulatory CMC strategies for device & combination products to ensure successful approvals in key markets and Compliance throughout development and lifecycle. Performs risk analysis for determination of probability
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,
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
Lead, motivate and mentor your team to maximize their effectiveness by clearly communicating task details and goals to your team members, allowing them to work effectively. Foster a positive progressive culture within the lab that focuses on EED&I
Maximizes development of staff through guidance, coaching, training, and performance management. Provides leadership, direction and management to staff related to monitoring, enrollment and/or site management to ensure deliverables are met. Contributes to
You'll drive the development and implementation of decision-enabling translational medicine strategies for our robust Immunology and Inflammation pipeline, with a specific focus on dermatology and/or respiratory diseases. Provide scientific, biomarker and
Ensuring the highest quality standards from subcontractors in line with current regulations and good practices (GxP), and delivery of reliable clinical data within agreed timelines. Oversight of early‑phase clinical trials (Phase I–II) in
The role assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site/Global QMS GMP policies and procedures. Additional responsibilities will ensure departmental
Ensures the contamination control and mibcrobiological quality control of the Sanofi-products in a complex environment and within the strongly regulated area of the production of active substances with the chosen quality strategy, the applied processes
This leader will be instrumental in ensuring robust manufacturing processes, seamless technology transfers, scale-up, validation, and lifecycle management of drug substance and drug product across our portfolio. This is a highly visible role at the
You will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management, risk
Provide strategic medical leadership across CEE in alignment with global and regional priorities; Lead and inspire regional medical team; Drive CEE regional medical strategy and execution in alignment with Sobi’s global and brand priorities
Ensuring effective and efficient Quality Operations in compliance with legal requirements, standard operating procedures and evolving global regulatory expectations; Optimizing the global Quality Management System to deliver fit for purpose processes
Work with the Global Regulatory Lead and Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents include (not limited to),
You will combine strategic leadership with hands-on execution. You will be responsible for designing, building, and leading the clinical operations function, while directly overseeing early-phase clinical trials. Lead the strategic planning and execution
This pivotal role is responsible for maintaining supply chain integrity and product quality across API, cosmetics, drugs, devices, components, and finished products. You will be central to ensuring operational excellence, regulatory compliance, and
You will be at the forefront of our mission, contributing to important new projects and ensuring our products meet the highest standards of clinical excellence. Your ability to navigate complex challenges and cope with frequent changes as well as your
You will be responsible for defining and implementing the regulatory pathway, from early strategy through to dossier submission, working closely with CMC, Clinical, Medical, and Quality teams. Define and implement the global registration strategy (Main
Medical lead for dedicated projects driving the launch of Key Brand in Nephrology. This role focuses on building and executing the medical plan for launch activities and supporting cross-functional launch preparation ex-USA, while adhering to the highest
Scientific and technical management of the in vitro DDI-Profiling laboratory, including supervising personnel. Responsible for the resource-conscious deployment and work allocation of employees, supporting other laboratories in the event of bottlenecks,
Build and manage long term relationships with key physicians, sites and partners while also leading medical strategy and tactics across our diverse geographic locations. This individual will be a strategic partner to indirect affiliates as well as
Ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies. This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing
In this role, the candidate will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW. The candidate may also
Ensure compliance with all applicable cGMP directives, regulations, and guidelines to maintain the high quality of pharmaceutical products; Lead and oversee deviation investigations, ensuring compliance with Teva corporate procedures and local quality
You will define and lead the safety assessment strategy across Evotec drug discovery and development portfolio, ensuring robust, science‑driven decision‑making from early concept through regulatory submission. Serving as the key interface
Lead the creation and execution of the country medical plans in alignment with the business objectives of the Insulet’s affiliate. The medical plans encompass value-generating activities on medical education, evidence generation
In this role, you will own and expand our clinical brachy functions, translating clinical proof points into compelling value propositions, and influencing reimbursement strategies. You will develop and execute clinical market development plans,
You will lead TxM strategy and activities in the project Core Team and represent non-clinical DMPK strategy from late research onward - partnering across ADME/DMPK, non-clinical safety, quantitative pharmacology, formulation, and clinical pharmacology to
Develop and execute RH clinical plans supporting new product introduction, lifecycle management, and regulatory submissions; Translate product requirements and regulatory needs into practical study designs, including sample strategy, specimen sourcing,
In this role, you will provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs. You will be responsible for quality oversight, process
A senior leadership role responsible for the technical strategy and process excellence of drug product manufacturing at an Oral Solid Dosage manufacturing site. This includes technical oversight for drug product intermediates control strategy from spray
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.
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
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