Upsilon Global

Freelance/consultant regulatory affairs and submissions expert – DACH Region

Location
Homebased
Salary
hourly rate - €70-€80
Posted
16 Apr 2021
Closes
16 May 2021
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Freelance/consultant regulatory affairs and submissions expert – DACH Region  

Upsilon Global are seeking a freelance regulatory expert to support EC/RA submissions packages across the DACH region. You’ll be working closely with the Regulatory Manager to prepare and submit packages across Germany, Austria and Switzerland.  

 

Quick info:

Start date: May 2021

Contract length: 6 months

FTE: Variable, estimated at 0.5/0.6 fte

Client type: Small American CRO

Indication: Varied, but covering Cell and Gene Therapy, Regenerative Medicine and Oncology

Location: Home-based, Germany/Austria/Switzerland

 

Main Responsibilities

  • Co-ordinate clinical trial applications across the DACH region in collaboration with the Regulatory Manager
  • Perform local clinical trial applications across Germany, Austria and Switzerland 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 local languages, 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’