Upsilon Global

Senior Regulatory Associate - Permanent - Germany - Growing CRO

Location
Germany (DE)
Salary
€50,000 - €70,000 (DOE)
Posted
27 Apr 2021
Closes
27 May 2021
Ref
SRAG270421HH
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Upsilon Global are hiring for an experienced, senior regulatory expert in Germany to work alongside the Regulatory Manager to review, coordinate and complete EC/RA submissions in Germany and Austria (and Switzerland would be a bonus). Hands-on experience is essential in this fast moving and rapidly growing division. 

If the candidate would be able to take on regulatory lead roles partially, that would be lovely but if not, that is also fine if he/she is absolutely confident is the submission part.

As well as being the responsible person for the DACH region, you will also act as lead regulatory expert to oversee international submissions packages, working closely with the Head of Regulatory to coordinate the activities of local regulatory associates across Europe, as well as presenting at sponsor meetings, so you must be a positive leader and commercially confident.

This is a fantastic opportunity for anyone who’s looking for greater responsibility, leading both local and international submissions packages for a growing CRO. You must be autonomous and self-managed, as well as a confident leader and someone who can work closely with the global head of regulatory affairs as the company expands operations.

Our partner, a small/mid-sized CRO with 150 headcount globally, are one of Europe’s most exciting CROs, gaining international recognition for their performance, quality standards and training & development programmes.

Fantastic salary and benefits available, home-working, flexible hours and great management and support structure. 

Main responsibilities:

  • Co-ordinate clinical trial applications in various countries in collaboration with cross-functional teams.
  • Perform local clinical trial applications across DACH region 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.

Job Requirements Qualifications:

  • 5 - 7 years’ 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, both oral and written.
  • Excellent communication, planning and organizational skills.
  • Demonstrated ability to work effectively in a fast-paced environment.
  • Proficiency in standard MS Office applications.

Please contact Harry Henson on harry.henson@upsilonglobal.com or +44 203 875 9966 for a further discussion about the role!

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