Freelance Regulatory Expert for EC/RA Submissions, Italy

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:

1. Start date: Feb 2021
2. Contract length: 12 months
3. FTE: Variable, estimated at 0.5 fte
4. Client type: Small European CRO
5. Indication: Varied, but covering Cell and Gene Therapy, Regenerative Medicine and Oncology
6. 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’