Find jobs in clinical research, clinical trials, CROs, Pharmacovigilance and Medical Information, and Regulatory Affairs. Find a job as a Clinical Research Associate (CRA) or Clinical Research Manager.
Clinical Research jobs in Belgium (1), Bulgaria (2), Croatia (2), Denmark (5), France (5), Germany (2), Greece (1), Ireland (5), Multiple Countries (18), Poland (4), Romania (1), Spain (5), Switzerland (5) and United Kingdom (10).
A strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations.
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
You will lead the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across our diverse portfolio - from pharmaceuticals and medical devices to
As a functional expert within a small, innovative group, you will play a pivotal role in advancing our clinical development programs. In this highly collaborative environment, you will provide strategic guidance on pharmacokinetics (PK), pharmacodynamics
In this role, you will coordinate and track regulatory submissions, partnering with the Regulatory Lead to prepare high-quality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to
You will oversee a team responsible for managing the end-to-end regulatory artwork process for pharmaceutical and non-pharmaceutical products across Europe. In addition to your leadership responsibilities, you’ll remain actively involved in daily
Ensure the creation of high quality medical information content in a consistent and unbiased manner, while adhering to all applicable rules, regulations and SOPs. Develop and maintain material such as (Non)Standard Response Letters and Frequently Asked
Lead the clinical development organization within the immunology TA (over 50 physicians and scientists), supporting, mentoring and coaching the clinical development teams across indications and assets. Ensure appropriate resourcing of the clinical teams
Your key responsibilities will be to influence the performance of the quality system and the PV activities; to promote, maintain and improve compliance with the legal requirements; to maintain an overview of medicinal product safety profiles and any
Act as the representative of European regulatory team at the global regulatory team (GRT) for the designated projects needing diagnostics, and may also be required to represent diagnostic strategies to global cross-functional teams for specific topics;
Manage and lead projects under his/her responsibility. Provide regulatory support when preparing for and during GxP inspections for countries in scope. Contribute to oversight of regulatory submissions for DACH & Nordics. Responsible for all product
You will play a pivotal role in integrating quantitative modeling to accelerate the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug conjugates (ADCs). Drive the PMx strategy across non-clinical and clinical
Responsible for assisting with defining compound/program medical strategies and for leading select medical affairs projects within a specific compound or indication. Support GMA the development of the Global Medical Affairs strategy and execution of the
The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role may serve as regulatory representative on multidisciplinary product
Ensuring that all the activities performed are maintained in compliance with applicable regulations, that appropriate authorizations/licenses and certificates are in place and current and that the integrity and safety of product are maintained throughout
Provides guidance and oversight to internal and external project team members for the successful management of clinical operation activities in accordance with International Council on Harmonisation of Technical Requirements for Registration of
Research pertinent scientific/clinical information that may include but is not limited to: disease background, current standards of care, how the proposed intervention fits into the current and projected future treatment landscape, and competing
Аctively support from CMC-perspective the whole evaluation and execution of projects (such as site transfers, sourcing changes and volume transfers) and liaise with other team members to make sure that timelines are met. Plan Team activities