Contractor regulatory manager

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

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking a Contractor Regulatory Manager to join their Rome office. The role involves managing regulatory changes, ensuring compliance, and serving as a key contact with internal and external stakeholders. Ideal candidates will have extensive experience in regulatory affairs and strong leadership skills.

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 for ESOQ managed contractors.
• Serve as the main point of contact for Global Chemistry Manufacturing & Controls.

Conoscenze

Leadership

Negotiation

Communication

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

Position details: Expected placement at the Rome office with an 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: Rome

Primary Responsibilities

1. Initiate, review, and approve regulatory changes through Pfizer enterprise system (i.e., PDM) for changes initiated by or impacting ESOQ managed contractors.
2. Support the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations, and Post-approval variations.
3. Serve as the main point of contact for the Global Chemistry Manufacturing & Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices for regulatory activities involving ESOQ contractors.
4. Participate as the Regulatory Expert in Virtual Site Operating Teams (VSOT) or similar meetings for ESOQ managed contractors and, if needed, participate in Site Quality visits at the contractors.
5. Support and perform Lot Disposition for biotech semi-finished and finished products (if applicable).

Minimum Requirements

• Master’s degree in Science, Engineering, Pharmaceutical Sciences, or related technical discipline.
• 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.
• Advanced computer skills such as MS Office applications and good knowledge of enterprise systems like PDM, QTS Trackwise, Documentum platforms.
• Good command of English; multilingual skills are a benefit.
• Strong negotiation skills and diplomatic communication with internal and external customers.
• Excellent verbal and written communication, including presentation skills.
• Demonstrated leadership in managing cross-functional projects.
• Experience managing complex quality and compliance activities in a manufacturing plant or with a contractor.
• Ability to report remotely and work independently.

Preferred Qualifications

• Willingness to lead by example, proactive in problem-solving, collaborative, and an active listener.
• Ability to manage stressful situations effectively and focus on tasks under pressure.
• Willing to travel up to 10% if required.
• Broad GMP and technical knowledge to handle emerging issues.
• Developing conflict resolution skills.

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