Törzskönyvezés állások, munkák

Állatgyógyászati készítmények regisztrációs dokumentációjának, kiemelten Part II (Quality/CMC) részének elkészítése, strukturálása és naprakészen tartása a hatályos EU-s és hazai előírásoknak megfelelően....

• Archiválás céljából beérkező dokumentumok kezelése és az archiválási folyamatok ellenőrzése
• Klinikai vizsgálati dokumentumok archiválásra történő előkészítése
• Bibliográfiai és elektronikus dokumentumkezelési feladatok
• A hatályos GxP előírásoknak megfelelő munkavégzés

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

Risk-Manager 80 - 100 % (f/m/d) True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the field of ventilators. Hamilton Medical is a leading manufacturer of...

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

• 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

Technical Support Manager API (f/m/d) 80-100% The IMCD Group is a global market leader in the sales, marketing and distribution of specialty chemicals and ingredients. With a global network of industry experts, IMCD offers its suppliers and customers in the EMEA, Americas and Asia Pacific regions...

• 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

• Support legal and compliance activities across ONPG
• Monitor adherence to internal Standard Operating Procedures (SOPs) and relevant pharmaceutical laws and regulations
• Maintain and continuously improve ONPG's contract database

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...