Regular Affairs Manager

Regular Affairs Manager

GlaxoSmithKline Pte Ltd
Not Specified
Not Specified

Job Description

Job Description :

Site Name: Vietnam - Hanoi Posted Date: Jun 23 2022 Regulatory Affairs Manager (RM) will manage regulatory affairs in order to support business objectives in efficient ways and in compliance with local legislation. Reporting to Senior Regulatory Manager, RM will 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: Registration planning Making plan registration (ie. new, renewal, variation) of assigned products. Co-ordinating with Commercial, Medical, CS&L, QA and HUB in order to set up appropriate plan and strategy to be in line with business objectives. Registration management and implementation 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. 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. 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. Process improvements: Continuously review and make the appropriate changes in order to improve the internal and cross-functional process. QMS compliance and GSK policies. Others: Lead of Global PI Implementation, CMC variation (Vx), REQUIRE system (Vx) .LI-GSK Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Medical/ Pharmacy graduate In-depth knowledge of vaccines and pharmaceutical products and regulation. Experience in regulatory work and environment. Regulatory Technical Skills Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent people skills, experience of working in a complex matrix Analytical and strategic thinking Planning skill Decision-making Ability to work under high pressure Communication and negotiation skills .LI-GSK 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. 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.

A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.

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