Job title: Regulatory Specialist III – Submissions Delivery

Company: GlaxoSmithKline

Job description: Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jun 27 2022 Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Cons

Job Description : Site Name: Bengaluru Luxor North Tower Posted Date: Jun 27 2022 Ready to help shape the future of healthcare At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact stronger and more sustainable shareholder returns and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster accountable for impact – with clear ownership of goals and support to succeed and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Job Purpose – Assemble, link and publish submission packages that meet Regulatory Authority technical standards and GSK requirements and schedules. Key Responsibilities : Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format Participate & Lead in the creation and implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality. Deliver of complex submission packages independently, to agreed schedule and technical specification Check compliance of others’ work with requirements and standards Advise and assist authors with more complex or non-routine content preparation or document management procedures Support submission team review and approval procedures Knowledge/ Education / Previous Experience Required : A. Educational Background 1. Minimum Level of Education – Bachelors or Master’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment Area of Specialization – Chemistry, pharmacy or other related science or regulatory affairs Why is this Level of Education Required – Working in complex environment within a scientific organization 2. Preferred Level of Education – Master’s degree or higher in biological or healthcare science Area of Specialization – Chemistry, pharmacy or other related science or regulatory affairs Why is this Level of Education Preferred – Appropriate for a scientific environment B. Job-Related Experience: Minimum Level of Job-Related Experience required – 0-6 years of relevant experience of preparing electronic regulatory submissions. Excellent computer knowledge (e.g. MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer etc) and preferably experience with the use of complex IT tools in a large organization. Why is this Level of Experience Required – Submission publishing requires the use of complex IT tools and the need to comply with numerous regulatory standards. C. Other Job-Related Skills/Background – Service orientation, customer-focused Ability to work carefully under time constraints Good team worker 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 Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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. 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Expected salary:

Location: Bangalore, Karnataka

Job date: Wed, 29 Jun 2022 22:05:32 GMT

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