Regulatory Affairs Trainee

Supporting the Regulatory Department in terms of dossier preparations, follow-up activities, and system updates.

Key Responsibilities:

  • Updating regulatory correspondence files, trackers and submission archives.
  • Keeping regulatory databases (regulatory systems, trackers, etc.) up-to-date.
  • Updating the MoHDT system regularly.
  • Circulating the incoming HA letters via the MoHDT system to the responsible persons.
  • Assisting Veeva updates.
  • Supporting MoH submissions in terms of format and assisting e-submissions.
  • Assisting the regulatory department in the maintenance of global and local regulatory databases.
  • Ensuring efficient regulatory archive management.
  • Checking incoming HA letters in the EBS system if required.
  • Checking artwork components in terms of regulatory compliance.
  • Supporting regulatory team for MM report preparations.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

  • Min. 3rd year student in pharmacy or life sciences
  • Proficiency in computer skills
  • Good command of English
  • Strong communication skills
  • Prone to teamwork
  • Eager to learn through experience
  • Able to work at least 3 days/week for min. 6 months

Job Posting End Date:

1 April 2025

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.

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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