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Regulatory Affairs Manager

6-8 years
Not Disclosed
10 Jan. 1, 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 Manager – Contract Sales Organization (CSO)
Location: Milan
Company: IQVIA

Job Description

We are seeking a Regulatory Affairs Manager for our Contract Sales Organization (CSO) to manage regulatory and medical activities related to a diverse portfolio of products in the Specialty and Retail areas for a leading multinational pharmaceutical company.

Responsibilities

  • Oversee regulatory activities related to the production of medical-scientific promotional materials (including promotional and disease awareness materials).
  • Manage the medical-scientific service, supporting the Marketing team in content creation and reviewing final materials while defining regulatory boundaries.
  • Handle regulatory submissions of communication materials to AIFA (Italian Medicines Agency), ensuring compliance with regulatory requirements and interacting directly with relevant authorities. Serve as the primary point of contact between the company and regulatory bodies, managing communications and responding to requests for information.
  • Collaborate with the medical-scientific service representative at IQVIA to manage all relevant activities, including drafting and updating Standard Operating Procedures (SOPs) and maintaining the associated quality system.
  • Monitor post-marketing activities, overseeing compliance with promotional regulations and post-marketing surveillance.
  • Conduct training sessions for the field-force on regulations, compliance procedures, and medical-scientific product content.

Requirements

  • Degree in scientific disciplines (e.g., CTF, Pharmacy, Medicine, or Surgery).
  • 6-8 years of experience in Regulatory Affairs or Medical Affairs departments within pharmaceutical companies or regulatory consulting firms.
  • Knowledge of Italian and European regulatory frameworks for pharmaceuticals and ethical codes.
  • Attention to detail, precision, and accuracy in all tasks.
  • Excellent organizational skills and the ability to meet deadlines.
  • Ability to work both independently and as part of a team.
  • High flexibility, adaptability, and dynamic problem-solving capabilities.
  • Strong written and verbal communication skills.
  • Excellent command of English (both written and oral), with regular interaction with global stakeholders.

Work Location

Milan, Italy.