Regulatory Affairs Manager - Labelling
A leading medical technology company is advertising a vacancy for a Regulatory Affairs Manager - Labelling position. The organisation offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that improve patient and hospital outcomes. Based in Cambridge, this vacancy is an exciting opportunity to work with a company that is dedicated to improving the healthcare field.
- Apply expert labeling knowledge, industry experience, and business needs to provide strategic input to stakeholders (Reg Affairs, Regional Ops, Artwork, Commercial) for the creation and execution of all labeling packaging components and launch plans e.g. health authority requirements, colour, layout, pack sizes, languages, and branding.
- Develop EU package component labels according to regulations and company guidelines.
- Develop patient leaflet content using knowledge gained from previous interactions with health authority and patients and execute it through regulatory approval to ensure safe and effective use of company products.
- Oversee successful Readability Testing: establish and execute process to successful results, (Revise EU label, patient leaflet, packaging components, instructions for use (collectively referred to as PI)).
- Prepare protocol and share with vendor, request patient leaflet mock-up, attend pilot stage testing, and amend protocol/leaflet as necessary for main stage.
- Review and finalise readability testing report and ensure submission ready.
- Lead QRD compliance review of PI at all phases of health authority review and launch.
- Act as the labeling contact person for internal and external audits and inspections.
- Respond to labeling questions from health authorities for EU-central markets, review comments, and update PI & provide responses & updated mock-ups.
- Apply continuous improvement practices and processes by anticipating problem areas, looking at current processes and developing solutions, and escalating issues appropriately.
- Proactively identify opportunities or troubleshoot issues by utilising analytical skills to evaluate and interpret complex situations and problems using multiple sources of information with company systems and propose workarounds/corrective actions on LEXA, IMR, or EPIC for all European countries; provide daily support on above systems and TrackWise.
- Select and manage vendors for readability and linguistic reviews, including preparing responses to vendor queries.
- Initiate and manage translations for EU-central countries ensuring health authority timelines are met.
- Project manage timeline waivers and approve in LEXA.
- Triage and review deviation requests for appropriateness and completeness.
- Review and approve MAA EN master artwork to ensure compliance with approved mock-up/text mapping.
- Negotiate and address questions with EMA on specimens submitted prior to launch.
- Reportability of label changes to HA.
- Mentor junior team members and local regulatory and operations staff on End to End Labeling processes & systems as requested by supervisor.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.