Regulatory specialist- CTA/IND development delivery

Job description

Nombre del sítio: Bengaluru Luxor North Tower
Fecha de publicación: Dec 8 2022

Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy?  If so, this Regulatory Affairs Operations role could be an exciting opportunity to explore.

As a Regulatory Affairs Operations Staff, you will work with the Governance, Compliance, and the Systems team within Global Labelling to ensure that labelling updates in Online Product Authorisation and Lifecycle (OPAL) are monitored and managed in compliance with GSK procedures.

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

•             Coordinate data collection and reporting process for compliance with timelines for delivery of labelling updates with partners at global, regional, and local levels

•             Manage data collection, report dissemination, and follow-up for flagged events within an agreed schedule

•             Support the building of a tool and process for setting up baseline data, resource tracking, and forecasting

•             Work with Global Labelling teams to improve visibility and access to performance data

•             Assist the management team with reports to address performance queries (related to source data) and work with functional group to identify root causes of deviations, or ingredients of success

•             Support the system administration of the labelling systems, including training of global and local users, in accordance with GSK policies and procedures

•             Work closely with IT Business System Owners to coordinate solutions delivery and support, such as User Acceptance Testing

•             Support development and maintenance of labelling websites, Team sites, and other communication channels

•             Participate in other projects and activities that support other labelling functions, such as contributing to the implementation of changes to processes within Global Regulatory Affairs (GRA)

•             Escalate risks and variances from plan or target when appropriate

Why you?

Basic Qualifications:

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

·  Bachelor’s degree
·  Experience with Labelling systems, standard operating procedures, and legislative requirements
·  Experience with entry, tracking and registration data management systems
·  Regulatory document management experience, including experience with Documentum databases and MS team sites

Preferred Qualifications:

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

·  Master’s degree
·  Excellent verbal and written communications skills
·  Ability to work carefully under time constraints and prioritize accordingly
·  Adaptable to fast-paced environments with changing circumstances, direction, and strategy
·  Exposure to work within a regulated environment, ideally in drug development

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.

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.