Regulatory Affair Manager - Consumer Healthcare - HCMC
GSK
Vietnam
12 ngày trước

Your Responsibilities :

  • To ensure that all new OTC products are registered within the time frame so that they can be launched by marketing as per their marketing schedule in Vietnam and update the core team on a monthly basis.
  • To ensure the existing product licenses are maintained in time to support the continuance of product marketing schedule.
  • To ensure that the marketing department’s long range plans are in the regulatory list and to ensure registration is facilitated.
  • If products are not registered on time, product launches and associated financial planning will be disrupted.

  • To ensure that product positioning and claims are verified and are within the regulatory context .
  • Settle National Regulatory Agency’s queries on OTC and actively inter-communicates with the Indochina Cx Regulatory Head and Cx Regional / Global Regulatory Affairs.
  • To ensure that the product information and technical information of the marketed products comply with the information registered / notified to regulatory agencies and filed for audit request.
  • To ensure the updated information is registered / notified to regulatory agencies in the time frame required by Cx Regional / Global Regulatory Affairs.
  • To liaise with Cx Regional / Global Regulatory Affairs and our own Divisions in obtaining materials for regulatory submission purposes.
  • To ensure packaging artwork of OTC products is complied with local regulations and AW approved by Regulatory Authority
  • Train new regulatory regulations to other depts. of business
  • Basic qualifications : BS in Pharmacy

    BS in Pharmacy

    Preferred qualifications :

  • Excellent oral and written communication skills
  • Proven influence and impact skills across business levels and functions
  • Strong interpersonal and negotiation skills
  • Problem identification and solving skills
  • Ability to enable and drive change
  • Able to work effectively in English
  • Why GSK? :

    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.

    The Rep. Office of GlaxoSmithKline (GSK) Pte. Ltd. was set up in Vietnam in Jul 2002 following the merger of two pharmaceutical corporations SmithKline Beecham and Glaxo Welcome in Jan 2001.

    GSK Vietnam has been recognized as one of the best places to work and is listed amongst the best companies in the pharmaceutical, biotech and healthcare sectors.

    This acknowledges the progress GSK is making in areas such as people development and employee engagement, as well as a strong value-

    based culture with patient focus, integrity, transparency and respect for people at the heart of what we do.

    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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