Regulatory Affairs Assistant

7 days ago

Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 270,000 - 420,000 per year
Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.

A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Join our international team and support regulatory aspects of clinical research projects, streamlining communication, maintaining electronic systems and managing documents.

Hybrid model that allows working in the office (Prague, Czech Republic) and working from home

You will:

  • Be the point of contact for clinical project teams and support services on regulatory matters
  • Prepare draft regulatory/ethics submission dossier
  • Be responsible for document management such as filing, processing, translation, quality control 
  • Update and maintain (automated) tracking systems, working files, and schedules
  • Organize meetings, prepare agendas and minutes
Qualifications
  • College/University degree or an equivalent combination of education, training & experience
  • Full working proficiency in Czech (or Slovak) and English
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication and collaboration skills
  • Administrative work experience, preferably in an international setting is an asset
  • Prior experience in Clinical Research is a plus
Additional Information

Start your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

Our extensive onboarding and mentorship program will prepare you to fulfil your tasks with the highest standards, offering you:

  • Excellent and flexible working conditions.
  • A unique combination of team collaboration and independent work.
  • Competitive salary and benefits package.

If you'd like to hear more about PSI, our organic growth and company culture, and learn more about the studies that we run and our high repeat and referral business rates, please apply for this vacancy.

  • Regulatory Affairs Officer/Coordinator

    7 days ago

    Prague, Hlavní město Praha, Czech Republic Zentiva Full time 250,000 - 350,000 per year

    Are you looking to start your career in the pharmaceutical industry?We are seeking a Regulatory Affairs Officer/Coordinator to support our Markets Management team. This role is a fantastic opportunity to gain hands-on experience in Regulatory Affairs, work with international colleagues, and contribute to projects that make a real impact.What you'll doManage...

  • Regulatory Affairs Assistant

    7 days ago

    Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 360,000 - 420,000 per year

    Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need...

  • Regulatory Affairs Assistant

    7 days ago

    Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 300,000 - 450,000 per year

    Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need...

  • Regulatory Affairs Assistant

    2 days ago

    Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 450,000 - 550,000 per year

    Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need...

  • Drug Regulatory Affairs

    2 weeks ago

    Prague, Hlavní město Praha, Czech Republic Roche Full time 40,000 - 80,000 per year

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

  • Regulatory Affairs Officer

    3 days ago

    Prague, Hlavní město Praha, Czech Republic Zentiva Full time 25,000 - 40,000 per year

    MISSION STATEMENT Under supervision, executes administrative and specific RA activities to support Regulatory Operations team and RA organization, completes low-risk regulatory assignments, performs relevant regulatory data entry and maintenance, supports tasks related to implementation and maintenance of RA information systems used for the relevant...

  • Regulatory Affairs Officer

    3 days ago

    Prague, Hlavní město Praha, Czech Republic Zentiva Full time 360,000 - 420,000 per year

    MISSION STATEMENTUnder supervision, executes administrative and specific RA activities to support Regulatory Operations team and RA organization, completes low-risk regulatory assignments, performs relevant regulatory data entry and maintenance, supports tasks related to implementation and maintenance of RA information systems used for the relevant...

  • Regulatory Affairs Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Zentiva Full time 900,000 - 1,200,000 per year

    ÚČEL POZICE:Zodpovědnost za regulační procesy v rámci přiděleného portfolia ve spolupráci s příslušnými orgány.CO BUDE VAŠE PRÁCE:Příprava podkladů pro podání žádostí o registraci léků, prodloužení a změny v registraci a pro notifikaci výživových doplňků, zdravotnických prostředků a kosmetiky.Zodpovědnost za překlady...

  • Regulatory Affairs Specialist

    2 days ago

    Prague, Hlavní město Praha, Czech Republic Zentiva Full time 900,000 - 1,200,000 per year

    ÚČEL POZICE: Zodpovědnost za regulační procesy v rámci přiděleného portfolia ve spolupráci s příslušnými orgány.CO BUDE VAŠE PRÁCE:Příprava podkladů pro podání žádostí o registraci léků, prodloužení a změny v registraci a pro notifikaci výživových doplňků, zdravotnických prostředků a kosmetiky.Zodpovědnost za...

  • Senior Regulatory Officer

    7 days ago

    Prague, Hlavní město Praha, Czech Republic PSI CRO Full time 900,000 - 1,200,000 per year

    Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need...