Regulatory Affairs Assistant - innovative healthtech
HeliosX, United Kingdom

The Company

HeliosX is a group of healthtech startups, with fast-growing operations in the UK and USA.

We are dedicated to improving the quality, accessibility and affordability of healthcare for all. We’re on a mission to transform how healthcare and skincare are delivered, and we’re doing this through a market-disrupting combination of technology, science and excellent clinical care.

The Role

We are looking to recruit a proactive and experienced regulatory affairs assistant to help with our expanding regulatory workload. You will work collaboratively with all members of the regulatory and pharmacovigilance teams and will be tasked with providing regulatory support across the whole product life cycle.

• Assist in preparation of dossiers for MA applications
• Prepare responses to requests for information from regulatory authorities
• Liaise with regulatory authorities
• Preparation and submission of variations
• Ensure maintenance of regulatory databases and trackers
• Provide regulatory input on artwork and product information
• Raise and approve change controls
• Provide support to the pharmacovigilance team
• Help with expansion in our key target market of the CIS region and Middle East and Africa

Requirements

• BSc Life Science degree as a minimum
• Broad knowledge and awareness of the European regulatory guidelines and legislation
• Be an effective team member
• Knowledge of the drug development process
• Speak either Russian or Arabic

Job Rewards and Benefits