Freelance international regulatory lead - remote europe - homebased - united kingdom, united kingdom

upsilon global are seeking a freelance regulatory lead to be responsible for the delivery of international submissions packages on behalf of one of our european cro partners.

we re seeking someone with a thorough understanding of european clinical trial submissions at local and international level, exceptional organization skills and professional communication to internal and external stakeholders.

this is a fantastic opportunity to lead and coordinate a variety of regulatory packages from a diverse sponsor base, working closely with both the senior leadership team and local clinical and regulatory associates to deliver projects quickly and effectively.

quick info:

start date: july 2022

contract length: 12 months

fte: 1.0 fte

client type: european cro

indication: varied, but covering cell and gene therapy, regenerative medicine and oncology

location: home-based

main responsibilities:

co-ordinate clinical trial applications in various countries in collaboration with cross-functional teams.

lead on regional and cross-regional studies, working closely with regulatory leadership team for both strategic and operational activities

provide both scientific and strategic advice to clinical development programs for assigned studies

work closely with and influence asnm

perform local clinical trial applications across france and belgium 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:

10+ 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.

for further information on this opportunity and to learn of similar positions, please contact upsilon global on or email

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