Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization?  If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore.

As Regulatory Affairs Manager, you will manage regulatory activities for the manufacturing site, assist the Pharmacist Technical Director in all his tasks and missions as well as ensure follow up with regulatory authorities.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

• •            Ensure that all released products comply with the registration dossier and Good Manufacturing Practices (GMP).

  •            Participates in preparing documentation related to batch release.

  •            Prepares for the submission of importation permit, stock reports, production schedules, incineration requests, and various regulatory documents.

  •            Follow up of all the pharmaceutical operations carried out in the site.

  •            Preparation of the registration and variation files  in collaboration with the LOC regulatory team.

  •            Responsible for archiving within the regulatory department.

  •            Responsible for the monitoring of the performance indicators of his service by identifying continuous improvement actions in his area to achieve department and site objectives.

  •            Manages customer complaints by coordinating investigations with relevant services.

  •            Manages artworks on site from creation to approval in accordance with regulatory and QMS requirements.

  •            Ensures local regulatory monitoring and follows up on QRI sent by global.

Why you?

Basic Qualifications:

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

• Bachelor degree in pharmacy
• 3 to 5 years’ experience in local manufacturing regulatory affairs department.
• Good knowledge of the quality systems and GMP.
• Excellent written and verbal communication skills
• Fluency in English language
• Computer knowledge

Closing Date: 18 November 2024

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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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