Regulatory Affairs Manager

3 settimane fa


Milano, Lombardia, Italia W Executive S.R.L. A tempo pieno
Job Description:

We are seeking a highly skilled Regulatory Affairs Manager to join our team at W Executive S.R.L. The successful candidate will be responsible for ensuring that all our products meet the relevant government legislation and regulations, while prioritizing patient safety and efficacy.

The main responsibilities of this role include:
  • Managing the registration of pharmaceutical products, medical devices, and API in various countries and regions.
  • Supporting the maintenance of regulatory files and tracking databases to ensure timely access to company regulatory information.
  • Providing regulatory expertise to scientists and senior management on new product development and assisting with the preparation and submission of regulatory documentation.
  • Reviewing product and process documentation for assigned projects to ensure compliance with requirements and monitoring renewals to strict deadlines.
  • Acting as a liaison between multiple project teams to obtain significant information and answer queries that may arise.
  • Communicating design changes to existing products and company practices where necessary.
  • Planning and developing product trials and interpreting trial data, as well as participating in marketing activities for packaging or advertising approvals.
  • Staying up-to-date with the latest rules and regulations and giving presentations to regulatory authorities.
  • Writing standard harmonized regulatory affairs operating procedures for the company and coordinating local compliance activities.

Requirements:
  • Bachelor Degree in Life Science disciplines, preferably in Pharmacy/CTF/Biological Sciences/Chemistry.
  • A specialisation in Regulatory Affairs is a plus.
  • At least 5 years of experience in the regulatory field within the pharmaceutical industry, preferably in companies with manufacturing sites for medical products.
  • Knowledge of medicines legislation, GMP, and reference guidelines.
  • Experience with AIFA and AGES is preferred.
  • Fluent in both spoken and written English.
  • Fluency in another major European language is preferred.


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