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Contractor Regulatory Manager (fixed term contract).
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.
Hybrid work expected
Retribuzione annua: 34000€ - 40000€
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
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
Contractor Regulatory Manager (fixed term contract).
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.
Hybrid work expected
Retribuzione annua: 34000€ - 40000€
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
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
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