RA Labelling Manager

Descrizione del lavoro:

Manager Global Regulatory Affairs Labelling

Job Purpose:
The purpose of this role is to provide regulatory leadership, governance and expertise to one sub-category or a brand or a portfolio of products such that the labelling of existing products is successfully maintained globally.
In this role the individual will build a network of collaborative relationships within Global and Regional Regulatory Affairs to ensure the provision of accurate, evidence-based product information to healthcare professionals, patients and/or consumers for existing products according to (COMPANY NAME) Values.
In close collaboration with (e.g. Consumer Safety Sciences, Regulatory Categories, Clinical and Medical), the role is accountable for updating the existing Global datasheets (GDS), creating the supportive documentation to support both HSB approval and local PI implementation (regulatory files, CLD, response to questions) and providing Labelling expertise/information in RA activities.

Responsibilities:
In collaboration with all stakeholders (e.g. Regulatory Categories, Consumer Safety Sciences, Clinical and Medical) and for a sub-category, brand or portfolio of products:
* Update the GDS in line with established processes and systems.
* Create and revise the supportive documentation required for GDS approval at HSB.
* Present the GDS update and supportive documentation for approval by the HSB.
* Plan, prepare and deliver high quality regulatory files supporting local submission.
* Manage country labelling differences and support CLD process according to agreed standards.
* Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders.
* Ensure compliance of their actions by adhering to established processes, policies, SOPs and working instructions.
* Provide Labelling expertise/information for RA activities (e.g. renewal, PBRERs).
If applicable,
* Prepare GDS compliance metrics for presentation at GROC and complete follow up activity when required to ensure timely implementation of GDS updates in local markets.
* May act as labelling SME to support successful implementation of Regulatory Information Management systems, and act as SME for other regulatory systems and repositories as required.
* Provide training on labelling processes for Global and Regional RA.
* Support continuous improvement of labelling process and direct new policy or pioneer new processes or improvements to (COMPANY NAME)'s competitive advantage.
* May act as (COMPANY NAME) representative to external groups on specific task forces within labelling expertise (e.g. digital e-leaflet).

Education Requirements:
BA/BSC Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

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At (COMPANY NAME) we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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(COMPANY NAME) is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, (COMPANY NAME) may be required to capture and report expenses (COMPANY NAME) incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure (COMPANY NAME)'s compliance to all federal and state US Transparency requirements