Job Description

Site Name: Petaling Jaya Horizon Penthouse
Posted Date: Jun 19 2023
Are you looking for a Regulatory Affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Executive role could be an exciting opportunity to explore. As a Regulatory Affairs Executive, you will be responsible for:

• To protect the company\xe2\x80\x99s reputation and license to operate
• To ensure that our medicines reach patients in compliance with the dossier reviewed and approved by the regulator.
• To support GSK strategy through effective management of external stakeholders.
• To build effective internal relationships to become a true and valuable partner for key stakeholders.
• To give the company competitive advantage in highly complex and fast changing environment.
• To drive growth and access to medicines through innovative and effective regulatory solutions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• To register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei.
• To renew and maintain Product Registration Licenses in Malaysia and Brunei via a Third-Party Agent.
• Perform Life-Cycle Management of all registered products in Malaysia & Brunei such as PI/PIL Update, Artwork Changes, CMC Changes, Change of Sites, New Indications & Dosages Variations, and all other changes that affect the registered information within Regulatory Authorities in Malaysia & Brunei.
• To be the custodian for all matters pertaining to the registered products including archiving and retention of the product files.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Minimum 1-2 years of regulatory experience in a pharmaceutical environment.
• Bachelor\'s Degree in Biomedical Sciences, Pharmacy or related fields

Why GSK?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation 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\xe2\x80\x99s 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 \xe2\x80\x93 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. 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.