Description
We are seeking a Manager, Strategic Labelling & Development to join our Global Regulatory Affairs (GRA)- Labelling department within Research and Development. As a Labelling Manager in the US-based team, you will help support our exciting pipeline of new products and provide labelling support to colleagues in markets worldwide.
Responsibilities:
- Lead the development, authoring, and maintenance of Global Datasheets for new medicines, product line extensions, and early lifecycle products.
- Manage local prescribing and patient information through development and early post-approval stages.
- Partner with colleagues in global markets to support timely and consistent implementation of Global Datasheets.
- Author regulatory responses and supporting documentation relating to prescribing and patient information.
- Interface with key labelling, regulatory, clinical, safety, governance, and operational stakeholders across GSK.
- Maintain labelling documentation, data, and processes in relevant systems and databases.
Basic Qualifications:
- Degree in Pharmacy, Life Sciences, Biomedical Sciences, or related discipline.
- Experience in a relevant scientific, pharmacy, or healthcare-related field.
- Two or more years of experience interpreting complex scientific information and collaborating effectively in cross-functional environments.
Preferred Qualifications:
- Advanced degree, such as MSc, MPharm, PhD, or equivalent.
- Relevant labelling or related experience across pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance, or therapeutic areas.
- Strong written and verbal English communication skills.
- Proactive mindset with a focus on performance, continuous improvement, flexibility, leadership, and challenging ways of working to improve processes.
Benefits:
- Health care and other insurance benefits for employee and family.
- Retirement benefits.
- Paid holidays.
- Vacation.
- Paid caregiver/parental and medical leave.
Salary Range: $138,600 - $231,000 per year