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Contractor Regulatory Operations Associate (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 Operations Associate, will be in charge of for regulatory change management/renewal/query activities for products manufactured by External Supply Quality (ESQ) managed contractors.
Placement expected at the Rome office (hybrid work) with initial fixed-term contract (9 months).
Position according to the chemical collective bargaining agreement commensurate with experience.
Retribuzione annua: 34000€ - 40000€
Primary Responsibilities:
- Initiate, review and approve regulatory changes through Pfizer enterprise system 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) department or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors.
Qualifications
- Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline
- Min. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 years with Master’s degree)
- Good verbal & written skills
- 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
- Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment
- Able to report remotely and deliver work independently
- Show strong negotiation skills and customer focus
- Is diplomatic in communication with internal and external customers
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 Operations Associate (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 Operations Associate, will be in charge of for regulatory change management/renewal/query activities for products manufactured by External Supply Quality (ESQ) managed contractors.
Placement expected at the Rome office (hybrid work) with initial fixed-term contract (9 months).
Position according to the chemical collective bargaining agreement commensurate with experience.
Retribuzione annua: 34000€ - 40000€
Primary Responsibilities:
- Initiate, review and approve regulatory changes through Pfizer enterprise system 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) department or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors.
Qualifications
- Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline
- Min. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 years with Master’s degree)
- Good verbal & written skills
- 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
- Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment
- Able to report remotely and deliver work independently
- Show strong negotiation skills and customer focus
- Is diplomatic in communication with internal and external customers
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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