Senior Regulatory Affairs Manager

Site Name: Vietnam - Hanoi Posted Date: Jan 6 2023 As Senior Regulatory Affairs Manager , you will lead, manage and motivate vaccine regulatory affairs team and play a critical role in developing and implementing plan and working procedure of the department This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: 1. Planning and managing registration of vaccine products To ensure that all new products are registered within the time-frame upon the launching schedule of commercial To ensure that renewals of the existing products are obtained timely for the supply continuity. To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation. To ensure that all labelling updates are submitted and approved within the Target Submission Category (TSC) and aligned with the global prescription information. 2. Regulatory consultation To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory environment to line manager, other functional departments, above country. 3. Risk management Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives 4. Process improvements Continuously review and make the appropriate changes in order to improve the internal and cross-functional process 5. QMS compliance and GSK policies 6.Lead of CMC variation (Vx), REQUIRE system (Vx), Vx Advocacy 7. Others as assigned by HoD *LI- GSK Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Background of Pharmaceutical Science is required for the job In-depth knowledge of vaccines and pharmaceutical products and regulation Regulatory Technical Skills Project management experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Proven ability to work across internal functional teams Strong communication skills and a proven ability to work collaboratively Exposure to functional systems across the business Why GSK? 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 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. 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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