Regulatory Affairs Specialist Submission Assembly
6 days ago
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
Join us as a Regulatory Affairs Specialist in Submission Assembly and play a key role in ensuring the timely and accurate preparation of regulatory submissions. In this role, you will collaborate with cross-functional teams to deliver high-quality submission packages that meet regulatory requirements and support GSK's mission to get ahead of disease together. This is an exciting opportunity to grow your career, contribute to impactful work, and be part of a team that values innovation, inclusion, and collaboration.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Assemble, review, and publish regulatory submission packages in compliance with technical standards and timelines.
- Collaborate with cross-functional teams to ensure submission documents meet regulatory requirements.
- Maintain knowledge of regulatory authority rules and GSK standards for submission formats.
- Support submission team review and approval processes.
- Identify and address risks or variances in submission plans, ensuring timely delivery.
- Contribute to the development and implementation of best practices and procedures to improve submission processes.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in pharmacy, life sciences, or a related field.
- 2-3 years of relevant experience in regulatory affairs or a related field.
- Experience with regulatory submission processes and document management systems.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work effectively under time constraints and prioritize tasks.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Master's degree in a relevant field.
- Experience working in a regulated environment, ideally in drug development.
- Familiarity with global regulatory requirements and submission standards.
- Ability to adapt to fast-paced environments and changing priorities.
- Strong problem-solving skills and a proactive approach to challenges.
- Experience in training or mentoring team members.
This is an on-site role based in Egypt.
We encourage you to apply if you are passionate about making a difference and contributing to our mission. Join us and be part of a team that values collaboration, innovation, and inclusion.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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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Cairo, Cairo, Egypt GSK Full time 120,000 - 240,000 per yearJob Title: Regulatory Affairs Specialist Submission Assembly Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge...
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