Contractor regulatory manager

JR Italy; Roma; In loco; EUR 40.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector seeks a Regulatory Manager for their Rome office. This role involves overseeing regulatory changes, ensuring compliance, and serving as the main contact for various regulatory activities. Ideal candidates will have extensive experience in regulatory affairs and strong communication skills. The position offers a competitive salary based on experience and an initial fixed-term contract.

Competenze

• Minimum 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.

Mansioni

• Initiate, review and approve regulatory changes through Pfizer enterprise system.
• Provide support for closure of deficiency letters and regulatory requests.
• Main point of contact for regulatory activities involving ESOQ contractors.

Conoscenze

Negotiation

Communication

Leadership

Problem Solving

Formazione

Master’s degree in Science

Engineering

Pharmaceutical Sciences

Strumenti

MS Office

PDM

QTS Trackwise

Documentum

Descrizione del lavoro

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

CONTRACTOR REGULATORY MANAGER

It is offered: 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€.

Place of work: Roma

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).
• 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;
• 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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