Freelance Regulatory Expert for EC/RA Submissions, Italy
3 days left
- Experience Level
- Experienced (non-manager)
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.
- 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
- 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’
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