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Regulatory Affairs Manager

Aplica ya
Mapa de ubicación: Prague 8, Czechia Full time R1246907

Descripción del trabajo

"IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.    

Why IQVIA

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning"     

This role is a great opportunity for an experienced regulatory professional with broad regulatory experience and expertise to work with the world’s leading CRO. This position requires a demonstrable knowledge of operational experience in European regulatory affairs within the service industry or biopharmaceutical companies.

Job Title: Regulatory Affairs Manager

Location: Czech Republic / Slovakia

Working arrangement: Home based

JOB OVERVIEW

You will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s)

As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies.

Essential Functions

•Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries

•Submit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority, follow up on the local regulatory approval process for designated countries

•Preparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countries

•Artwork review and approval in client systems

•Manage multiple pharmaceutical products

•Act as subject matter expert in regulatory processes

• Acts as a Regulatory Team Leader on more complex projects, which may include authoring of regulatory documentation, filling application forms.  

• Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer comments

• Acts as a Subject matter expert in Regulatory knowledge in Chemistry, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.

• Project budget management

• Give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development

• possible exposure to present to clients on complex regulatory processes bid defense meetings

• Act as reviewer for regulatory standard operating procedures

•prepare and deliver internal regulatory training if required

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Experience

Typically requires 5+ years of prior relevant experience.

Education

Degree in Life science or related discipline

Skills and Abilities

  • Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls) relevant regulatory guideline related guidelines
  • Possesses a specific regulatory or technical expertise
  • Interpersonal communication (oral and written) and organization skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Demonstrates self-motivation and enthusiasm
  • Ability to adapt quickly to a rapidly changing environment
  • Knowledge of Maintenance of marking Authorization
  • Experience of preparing variation, renewal packages and artwork approvals.
  • Fluent in English and Czech language and able to effectively communicate complex business language to those who speak English as a second language.  

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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