Job title: Assistant Manager, Regulatory Affairs
Company: GlaxoSmithKline
Job description: Job Description : Site Name: India – Maharashtra – Worli Mumbai Posted Date: Oct 19 2022 Ready to help shape the future of healthcare? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of
Job Description : Site Name: India – Maharashtra – Worli Mumbai Posted Date: Oct 19 2022 Ready to help shape the future of healthcare 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. MAINTAINING GOVERNANCE & COMPLIANCE Assist Regulatory compliance manager in Planning and conduct of Management Monitoring as scheduled to assess effectiveness of controls. Track and ensure timely closure of all remedial, Corrective and Preventive actions as and when arising. Liaise with RA team member and LOC quality team for any open change control and ensure closure as per timelines. Support implementation of Internal Control Framework (ICF) for regulatory affairs function. Administrator for maintaining all local Regulatory Affairs SOPs Assist in Identifying, assessing, and communicating, all relevant Regulatory Intelligence received from external or internal sources. Assist Regulatory compliance manager, in preparing dashboard for Regulatory function. LABELLING REVIEW AND APPROVAL Author and update Product Prescribing Information. Perform QC checks to ensure prescribing Information tracker is up to date. Administrator for Prescribing Information for ensuring accurate archival of electronic records. MANAGEMENT OF API LICENCES FOR LOCAL PRODUCTS: Compile dossiers for import license for locally manufactured product and ensure timely submission and approval of the same to achieve supply as per GSK Requirement. COMPLETING MANDATORY & ROLE SPECIFIC TRAININGS Ensure Completion of mandatory Regulatory trainings for self and Team member in a timely manner. At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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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Expected salary:
Location: Mumbai, Maharashtra
Job date: Fri, 21 Oct 2022 22:14:41 GMT
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