Senior Regulatory Specialist CMC Renewals

Site Name: Egypt - Cairo
Posted Date: Dec 23 2025
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 You will help maintain the quality and availability of our medicines by leading Chemistry, Manufacturing and Controls (CMC) renewals. You will manage post-approval submissions, work with global and local partners, and help shape regulatory strategy. We value clear communicators who are curious, accountable, and eager to learn. This role offers growth, visible impact on patient access, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Manage multiple CMC renewals and post-approval submissions for pharmaceutical and vaccine products. - Define and implement regulatory strategies and prepare high-quality dossier modules. - Respond to health authority questions and coordinate timely updates to submissions. - Review dossiers for accuracy and compliance and identify risks and mitigation steps. - Work closely with Global Manufacturing & Supply, quality and local market teams to deliver submissions on time. - Suggest improvements to regulatory processes and support digital ways of working. Why You? Work arrangement This role is hybrid, based in Egypt with attendance at the Cairo office 2–3 times per week. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field. - Minimum three years’ experience in regulatory affairs or the pharmaceutical industry. - Practical knowledge of post-approval CMC requirements and dossier structure. - Strong written and verbal English communication skills. - Ability to manage several tasks and meet tight deadlines. - Attention to detail with good organisational skills. Preferred Qualification If you have the following characteristics, it would be a plus: - Master’s degree in a relevant discipline. - Experience working with international regulatory authorities or global submissions. - Familiarity with eCTD/CTD structure and CMC documentation. - Experience using regulatory document systems (for example, electronic submission or content management tools). - Project management experience or experience leading cross-functional initiatives. - Experience mentoring junior colleagues or performing peer reviews. How to apply We welcome applications from people with different backgrounds and experiences. If this role speaks to you, please apply and tell us how your skills and experience will help patients and your colleagues. We look forward to hearing from you.

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.