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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...
We are looking for an experienced Regulatory Affairs CMC (RA CMC) Associate Director, who will be responsible for RA CMC strategy support to second line regulatory approvals, as...
Astex is seeking to appoint an experienced and influential medicinal chemistry leader; passionate about working on FBDD in close collaboration with scientists across computational...
Provide GMP/GDP expertise and supervise the clinical trials supplies within the EU and Switzerland and ensure the correct handling of the IMP (Investigational Medicinal Product)...
Conduct protein analysis with use of Mass Spectrometry based methods, e.g peptide mapping, disulphide bridges mapping, post translational modifications, intact mass profiling etc.;...
The Head of Quality Operations is responsible for leading Amicus’ Quality Operations Team, ensuring a robust GMP Quality System and compliance of our Internal and External GMP...
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...
The right candidate will take full accountability for business result within assigned accounts through developing and implementing the regional/account plan. You will be...
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...
The Director, Immunology European Medical Engagement Lead (MEL) conducts critical activities that support advancing science, educating on evolving clinical practices, transforming...
Support of the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety Pharmacovigilance-PSPV) and country PV offices in anticipation of...
As a Medicinal Chemist, you'll play a vital role in the process of drug discovery projects, helping to create new and more effective medicines. Using a range of chemistry...
The Senior Director, Clinical Science will support BeiGene Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership...
Provide education on all aspects on two or more technologies or one highly specialized technology of assigned device(s), device handling, implantation and troubleshooting...
Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit; Play an...
As the Associate Director Prodcution in our Operations Department, you'll lead a dynamic team and play an important role in achieving the long-term objectives and annual plans of...
Provide DMPK scientific leadership across all stages of the portfolio; Oversee the quality and performance of all DMPK activities including interactions with external CRO’s and...
As a Senior Scientist in our Bioanalytical Development group, you will play a key role in designing experiments, managing laboratory activities, and ensuring the successful...
Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents. Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior...
You act as primary quality contact for the assigned product for both internal and external stakeholders in an international and very dynamic work environment from development until...
Lead design of preclinical and/or clinical studies needed to support health benefit claims. Author, update and maintain relevant scientific documentation. Work closely with Product...
As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to...
Design, plan and perform/supervise scientific experiments and contribute to project related scientific/technical activities under minimal supervision (e.g., interpret and report...
The primary focus of this job is to lead and guide the late stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services at...
Management of cases with pharmacovigilance and materiovigilance departments. Regular training of Sales resources (place of the radiopharmaceutical in the strategy tree of...
This position contributes to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more...
Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled...
The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In...
Drive and manage all medical affairs activities in close collaboration with the global and local medical affairs as well as cross-functional teams; Development and execution of...
Responsible for providing strategic regulatory guidance on the global pediatric development in alignment with and within the overall development of a product; Lead multiple...
In your role within the Pharmacokinetic Sciences (PKS) group, you will provide scientific input into drug discovery and/or development programs of our clients and establish...
Lead bioinformatics activities that support the wet-lab colleagues with the analysis of transcriptomics studies, will develop and optimize (new) (in silico) analytical methods to...
The successful candidate will integrate basic science research, bioanalysis, genomics, and informatics to advance programs into the clinic and leverage clinical findings to...
Planning, performing and interpreting metabolite profiling studies up to and including human ADME studies for regulatory submissions, including MIST evaluation. This will be...
Lead and manage QA EU & international (RoW excl North America) consisting of QA Supplier managers, ensuring compliance with GMP/GDP regulations; Responsible for a robust and...
In the Clinical Trial Execution Service department, your role will support our trial processes and activities in line with our go-to-market strategy for Investigational Medicinal...
In this role you will be leading an experienced team of analysts and senior analysts in the Quality Control department. This will involve planning against operational and supply...
The successful candidate will lead a team of bioinformaticians and data scientists to support preclinical drug discovery projects performed in partnership with our clients from the...
Lead and manage a scientific team of up to 15 Hcs, including experts in fields of oral formulation, pulmonary drug delivery, long acting and modified release dosage forms,...
The Medical Affairs Lead will co-lead the development of the medical plan and execution of the medical affairs activities for an immunology asset (autoinflammation), as well as...
Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan...