An excellent opportunity has arisen for a Regulatory Labelling Manager to join a global pharmaceutical company based in Hertfordshire. Within this role you will lead and support the product teams on the overall development, optimization and implementation of regulatory labelling strategy.
Drives and optimizes the strategy for the creation and maintenance of Core Data Sheet (CDS). Provide guidance and expertise to product teams on CDS supporting documents
Authors and maintains CDS, as well as manages the CDS processes in collaboration with regulatory product responsible and product team.
Drives and optimizes the strategy for the creation and maintenance of EU and US product information package. Authors and maintains these product information documents. Leads/contributes company responses to HA questions pertaining to EU and US labelling.
Provides regulatory strategic recommendations concerning acceptable labelling in regional markets, in collaboration with the relevant functions.
Guides and supports the implementation of CDS into the Local Product Labels and manages local label deviations.
Gives specific guidance on labelling regulatory issues such as legislation, guidelines, procedures to the Project teams.
Leads or contributes to establishment or improvement of working processes and standards
* Bachelor's degree or equivalent in life sciences or other relevant fields
Experience, Knowledge and Skills:
In-depth insight in regulatory affairs (preferably strategic labeling). Knowledge in market access is a plus.
Proven ability to lead cross-functional matrix teams with strong influencing skills.
Good interpersonal and verbal communication skills
3-5 years' experience
Experience in Pharma - labelling and regulatory
Managing the group - data sheets, looking after EU and US labels.
Cross-functional experience required.
Home working, will be assessed after 3 months of office working
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to email@example.com