Regulatory Affairs Specialist

Regulatory Affairs/ Regulatory Affairs Specialist

Regulatory Affairs Specialist

Neopharmed Gentili SpA, an Italian pharmaceutical company specialized in the commercialization of high-value therapeutic solutions and a key player in the national pharmaceutical market — currently expanding at an international level — is seeking a Regulatory Affairs Specialist.

Role Description

The selected candidate will report to a Manager or Senior Specialist within the Regulatory Affairs Department and will provide technical-regulatory support aimed at obtaining Marketing Authorization (MA) for new medicinal products, as well as maintaining existing MAs through renewals and the variations required for business needs and/or compliance with regulatory requirements.

Similar technical-regulatory support is also required to ensure compliance with the regulations applicable to other product categories in the company portfolio, including medical devices and food supplements.

Requirements

  • Degree in Chemistry and Pharmaceutical Technologies, Pharmacy, or other scientific disciplines (biomedical or technological fields)
  • 3–5 years of experience in a similar role within structured organizations
  • Knowledge of European procedures for obtaining and maintaining Marketing Authorizations (MA): Centralized, DCP, MRP, National
  • Knowledge of the CTD structure and content, and tools for the creation and maintenance of eCTD
  • Knowledge and experience with procedures and documentation required for pricing and reimbursement applications
  • Excellent command of Microsoft Office (Word, Excel, PowerPoint)
  • Professional proficiency in written and spoken English
  • Strong analytical skills, organizational capabilities, problemsolving attitude, accuracy, and flexibility
  • Ability to work both in a team and independently, ensuring timely completion of assigned tasks
  • Excellent interpersonal skills with the ability to liaise effectively with internal functions (e.g., Technical/Supply Chain, Pharmacovigilance, Medical, Marketing) and external stakeholders (e.g., AIFA and other Italian and foreign authorities, manufacturing sites, etc.)
  • A second-level Master’s degree in Regulatory Affairs and/or experience in international regulatory activities (EU and nonEU) will be considered a plus

What We Offer

  • Permanent employment contract
  • Position as Regulatory Affairs Specialist or Junior Specialist, based on experience
  • Smart Working: one day per week
  • Corporate Welfare

Start Date: Immediate availability

Workplace: Neopharmed Gentili SpA – Via S.G. Cottolengo, 15 – 20143 Milan

Send your application to: talent.acquisition@neogen.it

The job offer is open to all candidates in compliance with Legislative Decree 198/2006 and Legislative Decrees 215/2003 and 216/2003.

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