Job Title: CONTRACTOR REGULATORY MANAGER
Randstad Inhouse Services, specialty Pharma, is seeking a resource to join the regulatory team at Pfizer srl as a Contractor Regulatory Manager.
Contract Details
Type of Contract: Expected placement with an initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience.
Benefits: Hybrid work expected.
Responsibilities
* Initiate, review, and approve regulatory changes through Pfizer's enterprise system (PDM) for changes initiated by or impacting ESOQ managed contractors.
* Provide support for the closure of 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) department or Local Regulatory Affairs in Pfizer Country Offices for regulatory activities involving ESOQ contractors.
* As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESOQ managed contractors and if needed, participate in Site Quality visits at contractors.
* Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).
Qualifications
* Masters 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 language and multi-lingual is a benefit.
* Strong negotiation skills and diplomatic communication with internal and external customers.
* Strong verbal and written communication, including presentation skills.
* Demonstrated personal leadership to manage cross-functional projects.
* 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 tasks 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.