Based at GMS Jurong, the successful candidate will be reporting directly to the Regulatory Conformance Lead.
This is a permanent role.
You will also be responsible for:
• Provide regulatory support to ensure conformance of site documentation with registered details for both new and established products as part of product lifecycle management.
• Contribute to the development of regulatory strategies, ensure accuracy of submission package and co-ordinate with both central regulatory and site on regulatory submission to ensure timely regulatory approval.
• Interpret and provide good advice on regulatory and compliance requirements to ensure that strategic decision embraces regulatory requirements and organization standards.
• Conduct review of registered details of products for both organization and external parties to ensure implementation of required regulatory strategies and compliance with standards.
• Receive regulatory updates & disseminate relevant information to the appropriate people on site and provide specialist advice on the implication of legislation / requirements to the business
• Attend to regulatory requests especially queries from authorities, meeting stringent timelines
• Provide consultation services to departments regarding regulatory matters
• Conduct and support internal audits
In return, we offer the opportunity to further enhance your analytical skills in a world class pharmaceutical organization.
GSK’s dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
Why You?Basic qualifications:
• Good Honours Degree in Chemistry, Chemical Engineering or other relevant Science / Engineering discipline
• At least 2 years’ experience in the pharmaceutical industry
• Good knowledge in current Good Manufacturing Practice and relevant standards/ guidance, including ICH, EMEA and pharmacopoeia. Experience in manufacturing processes, laboratory operations, operational quality, or Compliance & Validation will be an advantage
• Possess good audit skills and detail knowledge of regulatory processes
• Excellent influencing, interpersonal & communication skills
• A strong team player with a keen interest to interact & work with people from other functions
You will have an advantage if you come with at least 2 years’ of relevant experience in the pharmaceutical industry, good knowledge in current Good Manufacturing Practice and relevant standards/ guidance, including ICH, EMEA and pharmacopoeia.
some experience in manufacturing processes, laboratory operations, operational quality, or Compliance & Validation good audit skills and detail knowledge of regulatory processes
GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its ‘Change the World list’ which recognizes companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.
GSK was the first pharmaceutical company to set up manufacturing operations in Singapore, growing to be one of GSK’s largest manufacturing centers outside of the UK.
The Jurong facility manufactures 16 active pharmaceutical ingredients used in a variety of GSK prescription medicines for the treatment of respiratory, HIV, gastro-intestinal, allergy, anti-viral and neurological conditions
You may apply for this position online by selecting the Apply now button.
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