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Regulatory Operations Specialist

2 mesi fa

Milano, Lombardia, Italia Randstad Italia spa A tempo pieno

At Randstad Italia spa, we are seeking a skilled Contractor Regulatory Operations Associate to join our team. This is a fantastic opportunity to work with a leading company in the pharma industry.

About the Role

This role will involve working closely with the regulatory team at Pfizer srl to manage regulatory change activities for products manufactured by External Supply Quality (ESQ) managed contractors.

The successful candidate will be responsible for initiating, reviewing and approving regulatory changes through Pfizer's enterprise system, as well as providing support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.

This is a critical role that requires strong communication skills, both written and verbal, as well as advanced computer skills such as MS Office applications and knowledge of enterprise systems like PDM, QTS Trackwise, Documentum platforms.

Key Responsibilities
  • Initiate, review and approve regulatory changes through Pfizer's enterprise system.
  • Provide support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
  • Main point of contact for GlobalChemistry Manufacturing&Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for regulatory activities involving ESOQ contractors.
  • Participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and site quality visits at contractors as needed.
Requirements

To be successful in this role, you will need:

  • Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline.
  • Min. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year with Masters degree).
  • Good verbal & written skills.
  • Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems like PDM, QTS Trackwise, Documentum platforms.
  • Strong verbal and written communication skills including presentation skills.
  • Able to work in diverse multi-level, cross-divisional and multi-cultural working environment.
  • Able to report remotely and deliver work independently.
  • Show strong negotiation skills and customer focus.
  • Is diplomatic in communication with internal and external customers.
Estimated Salary Range

We offer an estimated salary range of €50,000 - €65,000 per year, depending on your experience and qualifications.

Location

This role is based in Milan, Italy.