Labelling Strategy and Development, Oncology Team Lead

01 ago - Italia
Gsk

Position Summary Qualsiasi informazione aggiuntiva su questo lavoro è disponibile nel testo sottostante. Si assicuri di leggere attentamente, quindi invii la sua candidatura. As a therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team for oncology products. You will engage with key stakeholders across R&D; to ensure effective development of GSK oncology labels, shape clear, compliant labelling that supports patient care and product success, and deliver practical regulatory solutions. Responsibilities Manage, train, and motivate a team of global labelling professionals for the oncology portfolio. Accountable for the management of the GSK labelling process for the development portfolio from early development through to early lifecycle management. Ensure compliance with regulatory requirements (e.g., related to product information, submission strategy) and work with matrix teams to resolve issues proactively. Provide strategic direction for labelling governance issues for the assigned therapeutic area and serve on the Global Labelling Committee.



Advise Regulatory and senior management on issues relating to product labelling, interfacing with senior leaders across R&D;, Safety, Regulatory and Commercial to develop, implement, and maintain policies and standards. Engage with Regulatory Authorities on labelling standards and policies directly or collectively through professional organizations to drive innovative labelling approaches. Basic Qualifications Bachelor's degree in life sciences, pharmacy, medicine, or a related field. At least 5 years of regulatory affairs or labelling experience in the pharmaceutical or biotech industry with line and matrix leadership experience. 3+ years of experience leading global labelling development, submissions, or regulatory interactions. Preferred Qualifications Advanced degree (MS, PharmD, MD, or PhD) in a relevant scientific discipline. Experience in oncology therapeutic areas and familiarity

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