Regulatory Affairs Specialist

4 settimane fa

Milano, Lombardia, Italia W EXECUTIVE S.R.L. A tempo pieno
Regulatory Affairs Manager

W EXECUTIVE S.R.L. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our organization, you will be responsible for ensuring that our products meet all relevant regulatory requirements and standards.

Key Responsibilities:
  • Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
  • Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
  • Manage the registration of pharmaceutical products, as well as medical devices and API in your countries and regions.
  • Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
  • Provide regulatory expertise to scientists and senior management on new product development, and assist with the preparation and submission of regulatory documentation.
  • Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines.
  • Act as liaison between multiple project teams to obtain significant information as well as answer queries that may arise.
  • Communicate design changes to existing products and company practices where necessary.
  • Plan and develop product trials and interpret trial data, as well as take part in marketing activities for packaging or advertising approvals.
  • Stay up to date with the latest rules and regulations.
  • Give presentations to regulatory authorities.
  • Write appropriate standard harmonised regulatory affairs operating procedures for the company.
  • Coordinate local compliance activities: impact assessment on local Change Control, define the local regulatory strategy for drug product communications, in compliance with local regulation.
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 experience in regulatory field within 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.
  • Experience in using the various applications of the AIFA portal.
  • Good communication skills – both written and verbal.
  • Skills of team working, critical thinking and planning, meeting deadlines efficiently.
  • The ability to work under pressure and to tight deadlines.
  • Fluent in both spoken and written English. Fluency in another major European language is preferred.

Workplace: Milano

L'annuncio è rivolto ad ambo i sessi (D.lgs n. 198/2006) e nel rispetto di quanto disposto dall'art. 10 del D.Lgs n. 276/2003. I candidati sono invitati a leggere l'informativa privacy https://www.wexecutive.eu/privacy-policy ai sensi dell'art. 13 e art. 14 del Regolamento UE 2016/679 sulla protezione dei dati. Aut. Min. Prot. R.0000155 del 31/12/2021.

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