Descrizione dell'offerta
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.
Experience in the API sector is preferred.
Placement expected at the Milan office with initial fixed-term contract (12 months) with possibility of extension.
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 GlobalChemistry Manufacturing&Controls (GCMC) dpt 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 meeting for ESOQ 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. 6 years of experience in GXP setting (QA/QC/production) and/or CMC/Regulatory Affairs role (or 5 years with Masters 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.
Preferred requirements: Experience in chemical API fields
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad () ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).