CK Group are recruiting for Manager, Global Labelling to join a Global Pharmaceutical company. This will be a home-based role in anywhere in the UK.
Manager, Global Labelling Role:
- Understand the regional procedure for MA\'s post approval changes, extensions and renewals.
- Collaborate with key stakeholders to facilitate and lead cross-functional teams in the development, review, approval, and maintenance of the company core data sheets (CCDS) and product labelling.
- Develop solutions to global labelling regulations.
- Function independently as decision-maker on global labelling regulatory issues.
- Act as Subject matter expert (SME) on local, regional, and multi-country regulatory labelling requirements.
Key duties will include:
- Management of labelling strategy and timelines, attending kick off meetings and managed the development of communication plans, risk strategies and escalations for the global labelling development through to post-marketing regulatory submission/ approval strategies
- Coordinate and lead cross-functional teams in development and lifetime maintenance of TPP, CCDS and country product information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting documents, and coordinate review and approval of final submission.
- Provide tactical and strategic guidance and proposed strategies in relation to CPI development regulatory requirements, content, and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis.
- Engagement in necessary labelling team meetings to discuss any decisions for not making any label updates or discuss any findings for meaningful differences for registration types specific to USPI\'s, CRP SmPCs and MRP/DCP-SmPCs as necessary.
As Manager Global Labelling, you will require:
- A relevant Life Science degree.
- Proven experience creating and maintaining CCDS or/and SmPC and/or UPSI
- Demonstrated experience in Regulatory, R&D or relevant experience within pharmaceutical industry, with solid experience in labelling
- Experience of European regulatory procedures (Centralized, MRP and DCP
- Proven interpersonal skills, negotiating, communicating, coaching, and explaining.
Quote job ref 52238.
It is essential that applicants hold entitlement to work in the UK.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Contact: Ashleigh Williamson
- Phone: 0) 1438 870 022
- Reference: 52238
Website: CK Group
- Posted: 18th November 2021
- Expires: 16th December 2021