Job Title: Senior Regulatory Labelling Manager/Consultant (Labelling Strategy)

Location: UK and Europe – Fully Remote

Salary: Competitive Salary + Excellent Benefits

Employee Type: Permanent

This is an exciting opportunity to join a leading CRO and be a client dedicated to an innovative and growing biotech. You will work as a regulatory affairs labelling lead for developing and established drug programs and be accountable for driving global labelling strategies. This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting cross-functional teams with end-to-end labelling processes.

This role can be based in the UK or Europe and offers the right candidate a chance to take the lead on regulatory labelling processes. The position will focus on global markets, and previous US and ROW market experience is desirable.

Responsibilities:

Support end-to-end labelling processes, including driving labelling strategies for both development programs and established drugs, and oversee all operational labelling activities.
Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
Act as operational expert for the Global Labeling tracking in RIMs, ensure development and maintenance of templates, collaboration features and system upgrades.
Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation.
Support labeling inspection/audit readiness activities.
Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

Skills and Experience:

University Degree in a scientific degree.
Experienced in the following: CCDS, PIL, USPI, Target label profiles.
5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
Good working knowledge of key labeling regulations/guidance and past experience in label development
The ability to research and create comparator labeling documents
Electronic document management systems use and / or electronic submission experience
Solid understanding of requirements for tracking of labeling updates. Understanding of label development and submission processes preferred.
Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS). Ability to manage the review and approval of labeling in a document management system.
The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams
Fluent in English, written and spoken

To be considered for this position, you must be based in the following locations: Romania, Lithuania, Poland, Czechia, Hungary, Spain, Italy, Croatia, UK, Ireland, and Serbia. Please note this role does not offer sponsorship and the right candidate must hold the Full Right To Work.

For more information, please contact [email protected]