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Your specific focus area will be design and development of novel assay components that support the required assay sensitivity, specificity, and overall solution robustness to...
Daily guidance and supervision of experimental activities related to cancer antigen validation across multiple projects; Cross-functional collaboration with computational and...
Provides global regulatory leadership of assigned program(s); Develops global regulatory strategies, including risk assessment and mitigation strategies; Participates in strategic...
Generate impactful human cell-based and other in vitro biochemistry and structural biology data to support our small molecule and genetic medicine projects; Explore target...
You will lead research programs in collaboration with internal and external partners focused on the development of novel drug candidates for the treatment of chronic liver...
You will take charge of leading regulatory CMC strategy and execution for one or more transformative medicine programs. This pivotal role involves developing and implementing...
Implementing and maintaining pharmacovigilance activities and associated quality management system at the national level including oversight of such activities in other Hub...
You are responsible for clinical trial sample management in a GCP environment; You are responsible for streamlining processes across all different sample types; You manage/own...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
You will play a key part in developing next-generation industrially relevant cell expression systems or services for the production of complex therapeutic proteins. You will lead...
Execute QA operations in support of and in concert with Senior QA Leadership to drive results, establish objectives and ensure appropriate steps are taken to identify compliance...
Are you an experienced Regulatory Affairs leader with a passion for medical devices? Are you looking for a motivated and diverse department to empower, guide and mentor Applied...
You are responsible for providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical...
Demonstrating scientific and technical excellence in material science and/or plastic engineering to resolve complex material and process issues, ensuring the quality and integrity...
Providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace...
The position leads the Global Development Team for the Asset and works in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly...
Accountable for external PV vendor development and oversight, including quality, performance and compliance of cases, support budget review and strategies of tasks outsourced to...
In this pivotal role, you'll perform critical Quality Control testing using cutting-edge Bioassay and Microbiology techniques within a GMP testing environment, supporting mRNA...
The individual will have project responsibility for early discovery towards candidate selection and into the clinical phases of the development. They will be responsible for the...
You'll play a crucial role in managing compliance with evolving regulations like REACH, offering a challenging yet rewarding professional environment. In detail, you will...
Collection, investigation and evaluation of verification data, weak points as well as implementation and monitoring of corrective measures; Participation in the creation and...
You will be responsible for analyzing the relevance of regulatory changes and developments, articulating the type and degree of impact on life sciences companies, and providing...
Provides operational expertise, strategic insights, and cross-functional leadership that enables the delivery of assigned trials within quality standards, agreed upon timelines and...
You will play a crucial role in the development of tools and assays requiring introduction of genetic changes of various nature (e.g. gene knock-out, silencing, gene...
Develop and validate new processes and control paradigms in ambr250 workflows; Develop small scale model, and scale down models using high through put systems, such as the ambr250...
You will manage regulatory documentation, ensure compliance with evolving regulations, and act as a representative in product-related projects. You will also guide and support...
The right candidate plays a key role in the execution of country medical affairs plans and tactics and delivers regional/national clinical, scientific and technical educational...
You will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial...
As our new Associate Director/Director, Global PV Operations you will become responsible for PV Operations activities and provide strategic and operational PV/quality/safety...
In this role you are responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the...
Provision of scientific and technical leadership to multidisciplinary teams to achieve corporate goals for challenging research projects within biologics early drug development...
In this role, you will oversee QC microbiology activities at contract manufacturing and testing organizations globally, leading QC raw material, drug substance, and finished...
Establish the EMEA regulatory strategy for marketed and pipeline products and ensure it is in line with the global regulatory strategy, taking into account the diverse needs of the...
Develop and implement regulatory strategies for successful product approvals; Provide strategic guidance to cross-functional teams on regulatory requirements and risks Ensure...
The Medical Affairs Manager provides support to the Clinical Evaluation Group for ongoingly assess the safety and performance clinical data of the Bausch+Lomb Surgical Medical...
You will play a crucial role in the QA Medical Device team who is responsible for establishing relevant procedures for own activities as well as provide guidance and support to...
Provision of regulatory input and support to Post-Approval Regulatory procedures in EU and ROW (document quality and accuracy, coordination of input from other line functions,...
You are responsible for the management of the QA activities related to manufacturing operations, as well as the QA support of the industrial technology transfer of the product when...
In this role, you will be responsible for leading an operational team that provides a range of services related to laboratory analysis within clinical trials for our clients. This...
Ensure that all products in scope are designed, manufactured and distributed in such a way that they are safe and effective for their intended use and meet applicable regulatory...
You will be responsible for leading the Global Quality Management Systems team with responsibility for the Quality Management Systems (QMS). The primary role of this position will...
Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting; Perform safety signal management and benefit risk...
You will provide leadership and QA expertise to manage the lifecycle of products available on the market including submissions, launches, product improvements, and phase-outs. You...
Lead, manage, and develop multiple laboratory teams, fostering a culture of excellence and continuous improvement. Oversee protein analytical methods, including method development...
You will be responsible for a wide range of activities related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. You will...
Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a...
You will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial...
Lead the development and manufacture of various formulation programmes; Contribute to the preparation and completion of documentation for development and clinical products such as...