Regulatory Specialist - RIM Manager

Site Name: Bengaluru Luxor North Tower Posted Date: Dec 7 2022 The information managed is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work, their direct reports and for the support of the large number of other users across GSK. Define, implement and oversee data quality monitoring procedures including regular data entry checks and the identification, investigation and remediation of quality issues Define system procedures, including reports, to support Business Processes effectively and manage change control procedures to ensure full impact assessment and robust implementation of change. Monitor ongoing user requests and system activity to identify and act upon potential quality issues or process improvement opportunities Develop, maintain and deliver training and support material, including Written Standards, to ensure appropriate and consistent use of Regulatory Information Management systems. Support assessments, audits and inspections with the provision of reports, systems expertise and advice on findings and recommendations Lead initiatives and projects to identify, recommend and adopt best practice for a global regulatory approach to document management and other Regulatory Information Management Systems (RIMS) initiatives. Partner with other managers globally within the functional area to address resource challengeswhen they arise Provide peer review and quality check support as requested and able Manages a team of direct reports including all day to day HR aspects, recruitment, even workload distribution and provision of escalation point for team members Independently manages multiple project assignments in the area of responsibility simultaneously; assignments will range in complexity but more complex work is expected 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing [email protected], so that we can confirm to you if the job is genuine.