Regulatory Affairs Specialist - Czech Republic
AbbViePragueUpdate time: February 19,2021
Job Description
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • Coordinate and support AbbVie Czech Republic affiliate for medicinal products and medicinal devices.
  • Provide Regulatory intelligence, regulatory vision and leadership to the Affiliate.
  • Build successful partnership with the regulatory agency and other regulatory authorities in the Czech Republic. Liaise with Corporate groups on regulatory matters and cooperation within the company.
  • Act as a coordinator for the labelling procedure for the Czech Republic for assigned medicinal products and medical devices. Review of materials, prepare and file of regulatory submissions and manage uploading related documents to relevant databases.
  • Participate in the business life of the affiliate and support affiliate initiatives.
  • Ensure compliance and data integrity, avoid potential risks to company reputation.
  • Ensure that all activities and interactions are conducted with due regard to all applicable laws, regulations, and the Company’s policies.

Qualifications
  • High School or University degree.
  • Good knowledge of local registration requirements regarding medicinal products and medical devices and previous experience of working in a similar position are needed, ideally in a multi-national pharmaceutical company.
  • Proficiency in written/ verbal Czech and English languages.
  • Computer skills – Microsoft Office, ability to familiarize oneself with new systems/ e-databases.
  • Thorough attention to detail and high standards of accuracy and the ability to work to tight deadlines. strong administrative skills.
  • Creative self-starter capable of working autonomously, with an interest in continued training.

Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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