Join BioGeneric Pharma S.A.E, a biotechnology leader in the Middle East, as a Senior Regulatory Affairs Specialist. Apply now and help shape the future of pharmaceutical compliance and innovation in Cairo, Egypt.
Join BioGeneric Pharma S.A.E – A Middle East Leader in Biotechnology Innovation
BioGeneric Pharma S.A.E (BGP), one of the most prestigious and rapidly growing biotechnology companies in the Middle East, is excited to announce a new career opportunity for a Senior Regulatory Affairs Specialist. Based in Cairo, Egypt (Sheraton Heliopolis), this role offers an exceptional chance to grow your regulatory career within an innovative environment that values science, strategy, and sustainability.
If you are a motivated, detail-oriented professional with deep expertise in regulatory submissions, dossier compilation, and health authority engagement, we invite you to apply for this exciting role.
About BioGeneric Pharma S.A.E
BioGeneric Pharma S.A.E is a recognized pioneer in biotechnology and pharmaceutical manufacturing, offering a wide array of biological and biosimilar products. With a robust infrastructure, advanced R&D facilities, and a focus on regulatory compliance and global health standards, BGP continues to lead the region in innovation and healthcare transformation.
Our mission is to make high-quality, affordable biotech medicines accessible across the Middle East, Africa, and beyond—empowering communities and improving public health outcomes.
Job Title: Senior Regulatory Affairs Specialist
📍 Location: BGP Scientific Office, Sheraton Heliopolis, Cairo, Egypt
🕒 Job Type: Full-Time
📧 Application Email: hr@biogenericpharma.com
📅 Application Deadline: Open until filled
💼 Department: Regulatory Affairs
About the Role
As a Senior Regulatory Affairs Specialist, you will manage the full lifecycle of regulatory submissions, ensuring all activities comply with international and regional regulatory frameworks such as EDA (Egyptian Drug Authority), EMA (European Medicines Agency), and FDA (U.S. Food and Drug Administration).
This strategic role also involves frequent collaboration with internal departments and regulatory bodies, making it vital for the successful approval, renewal, and variation of pharmaceutical products—especially biological drugs and vaccines.
Key Responsibilities
As a Senior Regulatory Affairs Specialist, your duties will include, but are not limited to:
1. Regulatory Submissions & Dossier Management
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Prepare, review, and submit regulatory dossiers in CTD (Common Technical Document) format for biological and pharmaceutical products.
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Compile, coordinate, and ensure the completeness of documents for product registration, variations, renewals, and post-approval activities.
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Liaise with external vendors and internal teams to obtain the required documentation for timely submissions.
2. Liaison with Regulatory Authorities
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Establish and maintain proactive, professional communication with local and international health authorities (EDA, EMA, FDA).
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Address regulatory queries with precision, ensuring clarity and accuracy of responses.
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Track submission statuses and maintain up-to-date records of ongoing regulatory processes.
3. Cross-Functional Collaboration
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Work closely with R&D, Quality Assurance, Business Development, Manufacturing, and Commercial teams.
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Ensure alignment of regulatory strategies with overall business goals and timelines.
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Provide regulatory input during product development and lifecycle management.
4. Regulatory Intelligence & Compliance
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Stay abreast of global regulatory trends, legislative updates, and guideline revisions.
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Interpret and apply regulatory requirements to ensure full compliance and reduce risk exposure.
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Actively participate in internal audits, training sessions, and risk assessments.
5. Strategy & Documentation
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Develop and execute robust regulatory strategies to accelerate product approvals.
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Ensure timely execution of post-approval variations, renewals, labeling changes, and packaging compliance.
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Contribute to process optimization and regulatory documentation quality improvements.
Preferred Qualifications & Experience
Educational Background:
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Bachelor’s degree in Pharmacy, Biotechnology, or Life Sciences from an accredited institution.
Professional Experience:
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Minimum 5 years of progressive experience in Regulatory Affairs within the pharmaceutical/biotech industry.
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Proven expertise in preparing and submitting CTD files.
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Experience in the registration of biological products, vaccines, and biosimilars is highly desirable.
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Familiarity with exportation procedures and region-specific regulatory requirements is a strong plus.
Regulatory Knowledge:
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Comprehensive knowledge of global regulatory systems, particularly EMA, FDA, and EDA.
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Understanding of ICH guidelines, GMP compliance, and pharmacovigilance support.
Skills & Competencies:
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Strong communication, negotiation, and interpersonal skills.
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High attention to detail and ability to analyze complex regulatory documents.
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Ability to manage multiple projects and deadlines efficiently.
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Proficient in regulatory software systems and Microsoft Office Suite.
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Fluency in English is mandatory; knowledge of Arabic or other languages is an asset.
Why Join BioGeneric Pharma?
At BioGeneric Pharma, we offer more than just a job. We provide a purpose-driven environment where you can make a real impact on patient lives through innovation and quality. Here’s what you can expect:
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Competitive salary and performance incentives
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Career development and training opportunities
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Exposure to global regulatory practices
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Collaborative and inclusive work culture
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Chance to work on groundbreaking biotech products
How to Apply
If you are passionate about regulatory science and meet the above qualifications, we encourage you to submit your CV and an optional cover letter to:
📧 Email: hr@biogenericpharma.com
📌 Subject Line: “Senior Regulatory Affairs Specialist Application – [Your Name]”
Qualified candidates will be contacted for interviews.
Location Advantage: Sheraton Heliopolis, Cairo
Our scientific office is strategically located in Sheraton Heliopolis, providing easy access to Cairo’s business hubs, government agencies, and transportation networks. This allows for efficient coordination with local stakeholders and health authorities.
At BioGeneric Pharma S.A.E, we’re shaping the future of health. Join us in this mission as a Senior Regulatory Affairs Specialist and play a vital role in bringing life-saving treatments to the market. Take the next step in your regulatory career with a company that values expertise, excellence, and ethical innovation.
📧 Apply Today: hr@biogenericpharma.com
