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Job Description
Roles & 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 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.
Desired Candidate Profile
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.
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.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Regulatory Specialist Assembly
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GlaxoSmithKline
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.