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As Regulatory Affairs Manager you will be responsible for:
To hold the Pharmacist Poison License Type A for the company to operate in Malaysia; and other licenses where appropriate [applicable for registered pharmacists only].
To register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei.
To renew and maintain Product Registration Licenses in Malaysia and Brunei. For Brunei, it is 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.
To create and approve artworks in Artwork Management System.
To ensure the created and approved Artworks for Market Specific Pack (MSP), Shared Pack, Multi Market Pack, General Export Pack (GEP), and all other Supplied artworks are in compliance with relevant national, regional and global labelling requirements.
To ensure compliance to QMS processes and Artwork Management SOP for Pharma and Vaccines.
To ensure timely revision of SOPs for compliance to the current regulatory requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
To protect the company’s 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
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Degree (Bio / Medical Sciences)
Minimum 5 years of regulatory experience in a pharmaceutical environment with experience in pharmaceutical product artwork management.
Knowledge of regulatory submissions to markets
Ability to ensure compliance standards and key performance indicators are met
Regulatory expertise in knowledge of the regulatory life cycle
Technical knowledge
Why GSK?
Uniting science, technology and talent to get ahead of disease 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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.
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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.
