Regulatory & Clinical Affairs Manager

Job Description

Job title & Local Job Title: Regulatory and Clinical Affairs Manager
Organisational Unit: Keto
Reports to: Healthcare Business Manager
Purpose of the role: To bring new products to market for the Kanso brand.

Key Accountabilities & Duties

Establishing and running the Regulatory Affairs function
• Manage ACBS application process from conception to launch, collating an evidence base to create compelling arguments for products being accepted to the UK market, and working closely with HQ to ensure all products and packaging meet UK requirements.
• Manage all regulatory requirements, ensuring products have been listed on all appropriate systems to enable them to be ordered.

Management of clinical trial projects

• Co-ordination of acceptability trials, to include recruiting the most appropriate centre, liaison with hospital R&D department, preparation of trial documentation and upload to IRAS.
• Create robust, realistic timelines and manage HCP’s to ensure timelines are met.
• Manage budgets associated with trials

Business Functions

• Relationship building with KOL’s and key HCP contacts at hospitals, in person and virtually, maintaining regular contact to ensure the Kanso brand is top of mind. Key point of contact for HCP’s.
• Alongside HBM and Director BU, develop business strategy & plan for Kanso
• Alongside HBM and HQ Marketing Team, input into communications plans for UK market, for HCP’s and patients as required, ensuring they are complaint with UK regulations.
• Provide holiday cover for HBM (point of contact)

Knowledge, Skills & Experience (inc Technical & Professional)

• Ideally 5 years regulatory affairs experience and clinical trials project management
• Highly organised with strong attention to detail
• Drives to achieve deadlines
• Strong decision maker
• Commercial understanding
• MS Office proficient