Regulatory Affairs Manager (18 months contract)

Basic qualifications:

Degree in Pharmacy

At a minimum 5 years of experience in Reg Affairs

Local regulatory experience on pharmaceuticals

Preferred qualifications:

Good knowledge of current regulatory requirements.

Good written and verbal communication skills

Strong stakeholder engagement skills

Details:

Our Company

At GlaxoSmithKline (GSK) we are dedicated to improving the quality of human life by enabling people to do more, feel better, live longer. GSK is one of the world's leading research based healthcare companies, with over 100,000 employees in 150 countries across our Pharmaceuticals, Vaccines and Consumer Healthcare business.

We are proud of the difference we make and in 2016, FORTUNE Magazine ranked GSK #1 on its list of companies that are changing the world. The 'Change the World' list recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy. Put simply, our focus is on improving access and affordability of medicines, regardless of where people live or their ability to pay.

GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.

GSK was the first pharmaceutical company to set up manufacturing operations in Singapore, growing to be one of GSK's largest manufacturing centres 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. Our Tuas site, one of only two GSK global vaccines manufacturing facilities worldwide, operates around-the-clock to manufacture, the active ingredient used to make a GSK vaccine that protects children against pneumonia. Our third GMS site is Quality Road, one of the world's largest amoxicillin facilities and Singapore's first pharmaceuticals manufacturing plant.

The Role

Based at our HQ GSK Asia House, the Regulatory Affairs manager will be required to support the business in Singapore by handling product registrations and maintaining product life cycle for pharmaceuticals and biologics. You will also be required to support regulatory initiatives and processes in line with

local and corporate requirements

.

Key Responsibilities:

  • Timely management of the registration activities including technical variations and

labelling updates

  • Work closely with the team and above country regulatory colleagues for prompt

response to regulatory queries.

  • Handle the regulatory activities on labelling updates, pack changes, artwork

development, proof reading and approval of artwork in line with registered details.

  • Build effective working relationships within regulatory team and other relevant local

stakeholders.

  • Comply with local, regional and corporate regulatory SOPs and other processes.
  • Support other regulatory activities such as local and central compliance activities,

product licences activities, due diligence checks.

Role Requirements:

During this 18 months' contract, you will work across various Therapy areas supporting regulatory and compliance activities. To be successful in this role, you must have the technical and clinical knowledge of pharmaceuticals gained from your academic, pre-registration training and your experience in Regulatory Affairs. You must be able to work with minimum supervision and work under pressure. With this role, we offer an opportunity to learn and develop your skills in an environment that focuses on continuous improvement and innovation.

What We Can Offer You

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.

Application Process

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.

If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply.

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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.


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