- Posted date 13 June 2022
- Job type Permanent
- Discipline Life Sciences
Job Title: Senior/Regulatory Affairs Manager - Global Labelling
Salary: £50,000 - £70,000 (dependant on experience) plus package including bonus
This is fantastic opportunity to work as part of a global consultancy division, embedded into the Regulatory team of a global pharma, taking lead on labelling activities aligned to new product launces and product registrations.
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.
Bachelor’s Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Exceptional candidates with 3+ years of labeling related experience may also be considered
- Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
- The ability to research and create comparator labeling documents
- Strong understanding and past experience creating annual reports
- The ability to collaborate with Tech Ops for artwork implementation
- Proficiency in SPL (all aspects, types and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
- Electronic document management systems use and / or electronic submission experience
For more details please apply with an updated version of your CV and I will be in touch to discuss further