Opis:
We are looking for a person for a global Pharmaceutical Company. If you are interested, submit your CV and start your career with a sense of purpose.
Oferujemy
- Opportunity to participate in trainings and improve skills
- Development opportunities with in the company structure
- Flexible working hours
- Work culture based on respect, honesty, transparency and focusing on consumer needs,Occasional temporary employment contract
- RandstadPlus - a system of benefits (sports card, private medical care, discounts on online shopping)
Zadania
- Managing multiple CMC variations and source transfers for Finished Products, Intermediates and Active Pharmaceutical Ingredients for pharma, biopharm and vaccines products (work with the CTD Module 3, Quality part of the dossiers)
- Managing assigned projects: define and agree regulatory strategy, complete data assessment to ensure authored regulatory dossier is in compliance with GlaxoSmithKline regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions), US and International countries
- Working with colleagues in Global Supply Chain, Global Regulatory Groups and GSK Local Operating Companies in markets worldwide to deliver high quality dossiers on time
- Building and maintaining good relationships with internal and external stakeholders
- Monitoring regulatory intelligence and acting proactively on identified changes to the regulatory requirements
- Identifying the improvement opportunities for CMC Regulatory processes, policies and systems
Oczekujemy
- Relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation)
- Bachelor’s or Master's degree in biotechnology, chemical technology, pharmacy, chemistry or other related science or technical field
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
- Attention to detail with emphasis on accuracy and completeness
- Ability to handle multiple tasks, to meet constantly shifting priorities and to schedule work to meet business needs
- Flexible and analytical thinking to independently provide solutions to issues
- Excellent interpersonal skills; ability to communicate clearly and effectively, work in a diverse team environment and build relationships across a large organization
- Excellent written and verbal communication skills in English and Polish
Agencja zatrudnienia – nr wpisu 47
ta oferta pracy przeznaczona jest dla osób powyżej 18 roku życia