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Regulatory Affairs Manager

2+ years
Not Disclosed
10 Dec. 10, 2024
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

Regulatory Affairs Manager – Prague, Czech Republic (1-Year Fixed Term Contract)
Innovative Medicines, Research & Development

About Novartis
At Novartis, we aim to reimagine medicine and improve lives. Our commitment to advancing healthcare relies on talented individuals like you, driving us to create breakthroughs that change patients' lives.

Role Overview
We are seeking a Regulatory Affairs Manager to join our team in Prague on an initial 1-year fixed-term contract. In this role, you will manage the registration activities for selected Novartis products, ensuring compliance with local regulatory and legal requirements related to packaging and presentation. Your work will play a crucial part in delivering our products to those who need them most.

Key Responsibilities

  • Manage Marketing Authorization Applications (MAAs), post-approval maintenance, and withdrawals of Novartis products in compliance with regulatory timelines.
  • Ensure timely reporting of regulatory changes in the Czech Republic (CR).
  • Oversee the preparation and approval of packaging materials in the local language.
  • Collaborate with product management to ensure optimal categorization and positive listings for our products.
  • Build and maintain professional relationships with key personnel at the State Institute for Drug Control (SÚKL).
  • Coordinate with other departments to ensure efficient use of resources for achieving sector success.
  • Report spontaneous adverse event (AE) reports and technical complaints related to Novartis products.
  • Handle the timely submission of renewals, variations, and new applications.
  • Ensure accurate and up-to-date entries in the local Drug Regulatory Affairs (DRA) database.

Experience and Qualifications

  • Degree in a healthcare-related field (preferably Pharmacist or Medical Doctor).
  • 1-2 years of experience in Regulatory Affairs or Pharmacovigilance.
  • Native Czech speaker with fluency in English.
  • Understanding of registration processes, local regulations, and legal directives.
  • Strong organizational and administrative skills, with attention to detail.
  • Knowledge of the competitive environment and commercial terminology.
  • Familiarity with regulatory standards and marketing/commercial needs.

Benefits and Rewards

  • Monthly pension contribution up to 3% of your gross monthly salary.
  • Risk Life Insurance (fully covered by Novartis).
  • 5 weeks of holiday per year.
  • 4 paid sick days without medical report.
  • Cafeteria benefits program with 12,500 CZK per year.
  • Meal vouchers (tax-covered by the company).
  • Car allowance, MultiSport Card, Employee Share Purchase Plan.

Why Novartis?
Join us in our mission to reimagine medicine and make a meaningful impact on global healthcare. At Novartis, we offer an inclusive, collaborative, and empowering environment for professional growth and innovation.

Join Our Novartis Network
Not the right role for you? Stay connected by joining our talent network for future opportunities.

Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. Please email di.cz@novartis.com for assistance.