Role: Global Labelling Lead
Location: United Kingdom - Remote
Salary: Very competitive salary on offer
Planet Pharma are supporting a leading global biotech company with the search for a new Global Labelling Lead to join them during an exciting period of growth! Perfect for someone looking to utilise their skills within an exciting biotech .
Role summary:
What the job looks like
Each day you'll enjoy a variety of challenges, such as:
Create and update core labelling documents:
* Lead the timely creation/management of regulatory compliant, competitive and up to date core labelling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet and Target Label Profile
Maintain labelling compliance
* Maintain labelling compliance for assigned products ensuring version control and tracking of CDS implementation in relevant company systems
Core labelling supporting documentation
* Oversee preparation of supporting documents for core labelling changes, in collaboration with Medical Writing, ensuring alignment to the core labelling strategy and global regulatory strategy
Oversee regional implementation:
* Oversee timely implementation of CDS updates in regional labels and monitor compliance to labelling processes
Requirements:
* 3 to 7 years pharmaceutical/ biotechnology industry regulatory experience, including regulatory labelling
* Experience with document management and regulatory tracking systems
* Effective cross-functional and cross-cultural skills to effectively interact with global counterparts
* Strong organizational skills, including the ability to prioritize personal workload
If you would like to discuss this vacancy further or to discuss your career options in confidence, please email me on: tcook-appiah@planet-pharma.co.uk
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.