Freelance Regulatory Expert for EC/RA Submissions, Italy - R-713

Freelance Regulatory Expert for EC/RA Submissions, Italy - R-713

13 feb
|
Upsilon Global
|
Italia

13 feb

Upsilon Global

Italia

*Freelance/consultant regulatory affairs and submissions expert – Italy  *Upsilon Global are hiring for an experienced regulatory consultant to create, review, coordinate and complete EC/RA submissions in Italy. You will work closely with the regulatory leads to ensure all submissions and performed as quickly and accurately as possible. *Quick info:* * *Start date: *Feb 2021 * *Contract length: *12 months * *FTE: *Variable, estimated at 0.5 fte * *Client type: *Small European CRO * *Indication: *Varied, but covering Cell and Gene Therapy, Regenerative Medicine and Oncology * *Location: *Home-based, Italy *Main Responsibilities* * Co-ordinate clinical trial applications in Italy in collaboration with cross-functional teams.

* Perform local clinical trial applications across Italy to ensure successful outcome. * Budget and contracts’ negotiation: draft or review site clinical trial agreements to ensure timely clinical trial start and compliance to the applicable local legislation. * Provide support for activities with outside vendors and business partners, as required (such as service agreements and work orders review). * Ensure that regulatory documentation and contracts are compliant to legal, regulatory regulations and company SOPs. * Facilitate proper filing of relevant documentation. * Ensure proper tracking of start-up activities in Company’s project management tools. * Track changes/amendments to legislative acts pertaining to clinical trials in participating countries and timely notification of all parties involved; liaise with other local teams to collate the relevant regulatory framework. * Assist in relevant SOPs and guidelines’ writing, maintenance. *Education and Qualifications* * Experience in managing regulatory aspects of clinical trials; good knowledge of relevant regulatory environment. * University degree in Life Sciences is preferred. * Excellent command of English and Italian, both oral and written. * Excellent communication, planning and organizational skills. * Demonstrated ability to work effectively in a fast-paced environment.For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0). 20. 3. 8. 75. 9. 96. 6. or email ‘applications (at) upsilonglobal . com’

Puoi trovare l'offerta di lavoro originale su Kit Lavoro:
https://www.kitlavoro.it/lavoro/21357464/freelance-regulatory-expert-for-submissions-italy-r-713-italia/?utm_source=html

Candidati a questo annuncio

Mostra le tue capacità professionali all'azienda, compila il form e lascia un tocco personale nella lettera di presentazione, aiuterà il recruiter nella scelta del candidato.

Iscriviti a questa job alert:
Inserisci il tuo indirizzo email, ti consentirà di essere sempre aggiornato sulle ultime offerte di lavoro per: freelance regulatory expert for ec/ra submissions, italy - r-713
Pubblica un nuovo annuncio gratuito
Hai bisogno di pubblicare un annuncio? Con oltre 1 milione di utenti unici al mese in breve troverai il candidato ideale per la tua Azienda, cosa aspetti!
Pubblica adesso

Iscriviti a questa job alert