Area állások, munkák törzskönyvezés kategóriában

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.

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

Swiss Regulatory Affairs Specialist About Brenntag Brenntag is the leading global distributor of chemicals and ingredients, committed to connecting customers and suppliers within networks. We add value for our customers and partners every step of the way: through our product knowledge, innovation,...

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...

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...

• 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

• 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.

• 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