Regulatory Specialist III

2 weeks ago

Bengaluru, Karnataka, India 14260 GSK India Global Services Private Limited Full time

Key Responsibilities

Regulatory Specialist RIMS is responsible for delivering the following key services to GRA colleagues in support of achieving GRA business objectives:

Responsibilities of this role are:

Supervise, mentor and support the work of junior colleagues. Supports in resource analysis to the manager to ensure obligations can be met. Accurate completion of more complex or non-routine data maintenance tasks to agreed schedule Sharing Subject Matter Expertise in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems and as well as understand the upcoming system changes and be part to propose or implement those changes ensuring readiness of the RIM team. Provision of primary support to end users of RIM systems and processes to enable efficient ways of working including: provide basic guidance, ad-hoc training, attendance at group meetings, provision of appropriate Reports etc Monitoring data quality routinely in order to identify and mitigate issues. Additionally, conducting root cause analysis and trend analysis to identify appropriate corrective/preventative actions Creation and maintenance of records (data and documents) within the company's Regulatory Information Management System (RIMS) with information provided 'on demand' by end users for all GRA Submission activities – typically supporting urgent 'timebound' requests. Streamlining regulatory information communication to Manufacturing and/or QA Release stakeholders to facilitate Supply Chain and QA Release operations Ensuring appropriate procedures are followed in the maintenance of System Reference Data Provision of support for system validation activities such as User Acceptance Testing, with a foundational understanding of the requirements of the Change Control procedures for enabling full impact assessment of any system/process change. Responsible for establishing & maintaining appropriate written standards where needed: SOP, WI, GUI, QRG & to continuous improvement projects and/or coordinating Key User fora, as RIM SME

Experience Required

1- 3years of experience in RIMS & Veeva Vault

Minimum Education :

Graduation/Post Graduation in Life Science Domain

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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