Global Labeling Lead - Homebased in the UK
- Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval. Control the consistency of labeling through review of content across the product family.
- Identify areas of potential non-compliance and supports investigations as needed. Escalate issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes. Identify potential non-compliance and supports investigations as needed.
- Lead and facilitate the global/regional labeling working groups to support the development of core and major regional labeling.
- Provide regulatory expertise and guidance for the development and submission of European labeling components. Control the consistency of European and ROW labeling content through alignment with the core documents across product families and with all applicable best practices.
- Generate target product label
- Generate USPI for new products and drive revisions for marketed products
- Generate SmPC for new products and drive revisions for marketed products
- Generate initial CCDS
- Bachelor's degree in a scientific discipline or related field.
- Minimum of 8 years of experience in regulatory affairs or labeling within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements and guidelines related to labeling.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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