Contractor regulatory manager 12 mesi roma

Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as

CONTRACTOR REGULATORY MANAGER

We offer: Expected placement at the Rome office with initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience. RAL 40.000€ - 50.000€.

Benefit : hybrid work expected

Primary Responsibilities

• initiate, review and approve regulatory changes through Pfizer enterprise system (i.e PDM) for changes initiated by or impacting ESOQ managed contractors;
• provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations;
• main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESOQ contractors;
• as the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors;
• support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable).

Basic qualifications:

• Master’s degree in Science, Engineering, Pharmaceutical Sciences or related technical discipline;
• min. 8 years of experience in GXP setting and/or Regulatory Affairs role;
• at least 4 years of Product Quality Assurance experience in a GMP environment;
• advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms;
• good command of English language and multi-lingual is a benefit;
• shows strong negotiation skills and is diplomatic in communication with internal and external customers;
• strong verbal and written communication including presentation skills;
• demonstrated personal leadership to manage cross functional project;
• demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor;
• able to report remotely and deliver work independently.

Preferred Qualifications:

• willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener;
• effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure;
• supervisory experience desirable;
• up to 10% travel if required;
• has a broad GMP and technical know-how to handle emerging issues;
• developing ability to resolve conflicts.

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