Contractor Regulatory Manager, Randstad

Randstad

Location:
Italy, Rome

Category:
Quality Control

Contract Type:
Not provided

Salary:

40000.00 - 50000.00 EUR / Year

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Job Description:

Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Manager. Expected placement at the Rome office with initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience.

Job Responsibility:

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)

Requirements:

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

Nice to have:

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

Additional Information:

Job Posted:
May 30, 2025

Expiration:
July 06, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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Contractor Regulatory Manager