Assistant Manager Labelling - Regulatory Affairs

Posted:
8/28/2024, 8:10:18 PM

Location(s):
Sindh, Pakistan ⋅ Karachi Division, Sindh, Pakistan

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Legal & Compliance

Job Purpose

To ensure adequate labelling processes are in place to comply with local regulations & also to meet GSK global labelling requirements.

Education, Experience & Skills

  • Pharm-D

  • More than 2 years of working experience in Regulatory Affairs of Pharmaceuticals

  • Experience in labelling or relevant areas of the pharmaceutical industry

  • Good understanding of local and global drug regulatory authorities’ guidelines on labelling

  • Knowledge of product labelling and packaging update

  • Compliance with new policies and SOPs of DRA Pakistan

  • Growth mindset and team player  

Key Responsibilities

  • Update Product prescribing information / labelling within the applicable TSC timelines  and communication to all relevant stakeholders. 

  • Update Single Market Product Information (SMPIs) with the support of SERM team (if required).

  • Assist in updating of leaflets/ labels text on cartons.

  • Maintain Team Site / share drive to keep up to date product prescribing information is available for commercial use.

  • Maintain PI tracker and keep the RV updated.

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.

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