Contractor Regulatory Manager (Fixed Term Contract) Lazio

Contractor Regulatory Manager (Fixed Term Contract)
Roma
Lazio, Lazio

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

CONTRACTOR REGULATORY MANAGER

Type of contract

: expected placement with initial fixed-term contract (12 months).

Position according to the chemical collective bargaining agreement commensurate with experience.

RAL 34. 000€ - 40. 000€.

Benefit

: hybrid work expected

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).

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.

--The search is aimed at candidates of both sexes (L. 903/77).

Please read the privacy policy in accordance with Article 13 of the Data Protection Regulation (EU) 2016/679 (GDPR) at