Regulatory Affairs Manager
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GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and consumer healthcare companies and is committed to improve the quality of human life by enabling people to do more, feel better and live longer.
In Malaysia, GSK has established a strong presence for over 50 years and is home to our operations in the area of pharmaceuticals, consumer healthcare, manufacturing, and Business Services Centre. GSK employs over 1000 staff in Malaysia.
GSK is an exciting, rewarding and dynamic place to work. We thrive to be different from the conventional corporate ways of working. We pride ourselves on exemplary leadership and sense of community, and we offer a great platform for your personal and career development.
GSK Consumer Healthcare
At Consumer Healthcare, we bring products to millions of people across three categories – Oral Health, Wellness, Nutrition and Skin Health. Many of our brands such as Panadol, Scott's, Sensodyne and Horlicks are familiar around the world. Our brands have been carefully made available to build consumers' trust and loyalty, through maintaining the highest standards in safety and efficacy, whilst bringing new innovations to the market place.
We are currently recruiting for a Regulatory Affairs Manager to join our Consumer Healthcare Division based in Ulu Klang.
This role provides regulatory and technical support as well as ensures that Consumer Healthcare dossiers are prepared based on regional country requirements.
To interface between the local manufacturing site and affiliate countries in the region.
Promoting interpersonal relationship with the members of government agency.
Register Consumer products in Malaysia, provide regulatory support in terms of obtaining COPP and other regulatory documents for regional country registration. Any queries raised by the Ministry of Health's Food Division on nutritionals must also be addressed.
- To contribute to the business objectives by assuring the quality of the products within the distribution chain of the local marketing company and promoting quality standards internally, as part of the Quality Management System, company culture and externally as part of the company's image.
- Successful completion of relevant tertiary qualifications – Pharmacy, Registered Pharmacist
- Minimum of 5-8 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager
- Knowledge of the registration process, specific local regulatory requirements, BPFK environment including organisation, people and trends, as well as regional regulatory development and collaborative initiatives.
- Basic understanding of drug pharmacology, toxicology, clinical study requirements and procedures, and clinical study and safety aspects pertaining to product registration applications.
- Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and audits
- Strong knowledge of regulatory requirements pertaining to GMP/GDP
- Good knowledge on effective quality documentation systems
PLEASE APPLY ONLINE
You may apply for this position online by selecting the Apply now button.
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