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Regulatory Affairs Talent Pool

1-3 years
Not Disclosed
10 Jan. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Talent Pool
Location: Budapest, Pest, Hungary
Category: Regulatory Affairs
Job ID: 202411-129170


About Roche:
At Roche, we believe that diversity is key to our success in providing exceptional care globally. We foster a culture of inclusion, where every voice matters and contributes to our mission to deliver innovative healthcare solutions. Join Roche, and together, we will push the frontiers of healthcare.


The Position:
As part of the Regulatory Operations Group, you'll contribute to Roche’s global Pharma Medicines Division by ensuring the accurate and timely submission of regulatory applications to health authorities. Working closely with multiple teams, including Clinical Trial Regulatory Management and Global Labeling, you'll support the development and maintenance of high-quality regulatory documents, ensuring compliance and adherence to standards across global teams.

In this role, you'll be expected to:

  • Compile, format, and publish regulatory documents, ensuring quality and consistency.
  • Support regulatory submissions and clinical trial operations.
  • Maintain and manage regulatory documents and data using regulatory management and document-sharing systems (e.g., Documentum, SharePoint).
  • Leverage your expertise to mentor new team members and improve operational efficiency.
  • Build strong collaborations within Roche’s diverse global teams, ensuring smooth regulatory operations.

Who You Are:
We are looking for passionate individuals with:

  • 1-3 years of experience in regulatory affairs or related fields (preferably with a life sciences degree).
  • Proficiency in IT, especially in Word, Excel, Acrobat, and experience with document management systems (e.g., Documentum, SharePoint).
  • Strong attention to detail, consistency, and formatting skills in regulatory documentation.
  • Excellent collaboration skills, with the ability to work in fast-paced, global teams.
  • Fluent in written and spoken English, with logical thinking and problem-solving abilities.

In Exchange, We Offer:

  • Development opportunities through Roche’s learning resources, including language courses, trainings, international assignments, and career shaping.
  • Competitive salary, cafeteria package, annual bonus, private medical services, and other benefits.
  • Flexibility in work arrangements, including home office (2 office days per week) and fully remote working within Hungary.
  • A global, diverse, and inclusive community where your ideas are valued.

Please Note:
This is a Talent Pool requisition, meaning it may not reflect an active recruitment process but is aimed at building a pool of potential candidates for future openings in this role.