Regulatory Affairs Operations

Job description

Nombre del sítio: Taiwan - Taipei
Fecha de publicación: Jan 16 2024

Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization?  If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.

As Regulatory Operations Manager, you will be responsible for leading or supporting strategic and operational Regulatory projects, which support business strategy and platform delivery.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

·  Fulfil standard, ad hoc, or complex data reporting request and design outputs.
·  Assist Regulatory Business Operations (RBO) staff in delivery of projects.
·  Assist RBO staff in process documentation, monitoring, and reporting.
·  Maintain Team sites.
·  Adhere to records retention.
·  Complete appropriate training.
·  Assist Regulatory Business Operations staff to optimize project plan robustness (scope, deliverables, resources, timing).
·  Provide project support to meet assigned business deliverables.
·  Edit existing process documentation and lead monitoring and reporting.
·  Provide analysis and interpretation of information in response to requests from requestors and pursue greater data quality through identification of gaps and delivery of efficient solutions.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  Bachelor’s degree.
·  3 years of pharmaceutical industry experience in a regulatory environment.
·  Experience with License Maintenance as well as overall R&D processes.
·  Direct experience with project planning & execution.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

·  Master’s degree or MBA
·  Experience working in a matrixed environment
·  Demonstrated ability to engage and influence senior stakeholders.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

·  Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
·  Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
·  Continuously looking for opportunities to learn, build skills and share learning.
·  Sustaining energy and well-being.
·  Building strong relationships and collaboration, honest and open conversations.
·  Budgeting and cost-consciousness.

DEI

GSK is an Equal Opportunity Employer and we want GSK to be a workplace where everyone can feel a sense of belonging and thrive. All qualified applicants will receive equal consideration for employment without regard to disability, race/ethnicity, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, or age.

Disability

GSK is committed to being inclusive for people with disabilities. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace where all our people can thrive. Since 2020, GSK has been an active member of the Valuable 500 pledge , a collection of 500 global companies all committed to placing disability inclusion on the leadership agenda. We are delivering on its objectives through our disability confidence plan.

*Li-GSK  

Nuestro objetivo es ser una de las empresas de atención médica más innovadoras, de mejor desempeño y más confiables del mundo. Creemos que todos aportamos algo único a GSK y cuando combinamos nuestros conocimientos, experiencias y estilos, el impacto es increíble. Únase a nuestra aventura en GSK donde se inspirará para hacer el mejor trabajo para nuestros pacientes y clientes. Un lugar donde puede ser usted mismo, sentirse bien y seguir creciendo.

  

Aviso importante a las empresas o agencias de empleo

GSK no acepta recomendaciones de empresas de empleo o agencias de empleo con respecto a las vacantes publicadas en este sitio. Todas las empresas o agencias de empleo están obligadas a ponerse en contacto con el Departamento de Contrataciones Comerciales y Generales o el Departamento de Recursos Humanos de GSK para obtener autorización previa por escrito antes de recomendar a cualquier candidato a GSK. La obtención de autorización previa por escrito es una condición precedente a cualquier acuerdo (verbal o escrito) entre la empresa o agencia de empleo y GSK. En ausencia de dicha autorización por escrito, se considerará que las acciones que emprenda la empresa o agencia de empleo se han realizado sin el consentimiento o el acuerdo contractual de GSK. Por lo tanto, GSK no será responsable de ninguna tarifa derivada de tales acciones o cualquier tarifa que surja de cualquier recomendación por parte de las empresas o agencias de empleo con respecto a las vacantes publicadas en este sitio.