Regulatory Affairs Manager

GlaxoSmithKline

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30 ngày trước

Planning and managing registration of assigned 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.

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: Perform of CMC variation (Vx), Vx Advocacy*LI- GSKWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:

Bachelor
Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
Taking charge of registration of vaccines, pharma products: building plan for registration, communicating with liaison and CMC team to get appropriate documents as well as finding the best solution, following up progress of dossier assessment, developing artwork and keeping regulatory system updated.
Collaborating with Marketing to build strategy for vaccine and new products (NCEs)
Supporting local vaccine release (providing documents, cold chain system, solving issues related to vaccine release in Vietnam) and supply activities
Updating drug legislation
In-depth knowledge of vaccines and pharmaceutical products and regulation.
Experience at least 05 years in regulatory work and environment.
Regulatory Technical Skills

Preferred Qualifications:If you have the following characteristics, it would be a plus:

List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.

Why GSK?Our values and expectations are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness

Why Us?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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. 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/ AgenciesGSK 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.

GlaxoSmithKline

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