Development állások, munkák törzskönyvezés kategóriában

Perform critical scientific and statistical interpretation of clinical data, providing clear insights to support sound, evidence-based decision-making....

Project Business Analyst- PaperlessLogbook Project Business Analyst: Business Analyst / Project Manager / GxP / CSV / Synthetic Molecules / GMP / Production Processes / English / German Project: For our client, a large pharmaceutical company based in Basel, we are looking for a Project Business...

CMC Specialist in Regulatory Affairs INNOMEDICA IS A YOUNG NANOTECH COMPANY with around 40 employees, several promising drugs in preclinical and clinical development and its own clean room production. The pipeline is based on a liposomal delivery system and includes, in particular, parenteral drug...

• Confirms, certifies, and releases batches of products manufactured, ensuring all manufacturing steps have been performed in compliance with GMP, the marketing authorization of the relevant product, defined procedures, and current regulations.
• Confirms batches of products intended for clinical trials.

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• Planning, writing, reviewing and submitting manuscripts on clinical drug trials in humans for peer-reviewed journals and abstracts for scientific conferences
• Data visualization of data from clinical drug trials
• Supporting preparation of posters and conference presentations

Scientific oversight and coordination of preclinical and toxicology studies conducted in collaboration with CROs, academic partners, and scientific institutions - covering both GLP-regulated and exploratory/non‑GLP research...

Active contribution to international projects in the areas of reimbursement and market access, including coordination, analysis, and substantive input on strategic topics...

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

Legal Advisory: Provide expert legal advice and guidance to senior management and legal colleagues on European regulations, directives, and policies impacting the business, including REACH, CLP, MDR/IVDR, GMP guidelines, pharmaceutical and/or medical device law, regulations, and guidance related to...

Lead Expert Quality Assurance, Deputy Responsible Person 40% Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

Global Market Access Manager The Global Market Access Manager will play a key role in enabling timely, sustainable patient access to mylife Diabetes care AID therapy across global markets. The mission of the role is to shape and execute the global market access strategy by anticipating payer,...