GSK

Regulatory Affairs Executive

Istanbul

October 10, 2024

Site Name: Turkey - Istanbul
Posted Date: Oct 10 2024

Key Responsibilities:

The role will be reporting to the Regulatory Manager with the following key responsibilities:
  • Supporting Regulatory Manager in all regulatory processes
  • Preparation and completion of regulatory submissions and approvals of NCEs (new chemical entities) within the defined timelines
  • Execution and follow-up regulatory processes for both locally manufactured and imported products.
  • Execution of maintenance activities of the registered products, including post-approval submissions (renewals, technical variations, new indication, label updates) and conducting effective cross-functional interactions to preserve business continuity
  • Execution of operational tasks
  • Follow up on the Mo H correspondences.
  • Participation in brand teams and giving input for regulatory activities and action plans.
  • Execution of GMP-related tasks including inspection submissions, which require close follow-up with internal and external stakeholders
  • Follow up on developments and changes in the local & global regulations and analyse the potential impact on the registrations

Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
  • Bachelor’s degree in related fields (such as Faculty of Pharmacy, Chemical Engineering, Chemistry, etc.)
  • Have min. 3 years experience in the regulatory field
  • Have a good command of written and spoken English
  • Strong command of communication and presentation skills
  • Good knowledge of MS Office tools
  • Strong planning, follow-up, reporting and analytical skills to achieve accurate and timely results,
  • Work precisely according to procedures, rules and regulations

Job Posting End Date:
24 October 2024

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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