Role Overview
We are seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to lead and manage regulatory strategy, submissions, and compliance in Egypt. This role requires deep expertise in regulatory frameworks, excellent project management skills, and a proactive approach to cross-functional collaboration.
Key Responsibilities
- Lead the preparation, review, and submission of regulatory dossiers/CTD for new product registrations, renewals, and variations.
- Liaise with health authorities, distributors, and internal stakeholders to ensure timely approvals and full compliance with regulatory requirements.
- Monitor changes in regulatory guidelines, assess their impact on company products and processes, and provide strategic recommendations.
- Develop and execute regulatory strategies that support product lifecycle management and business objectives.
- Ensure proper documentation, technical writing, and maintenance of regulatory records in line with company and regulatory standards.
- Collaborate with cross-functional teams including Medical, Quality, Marketing, and Supply Chain to support product development and market access initiatives.
- Drive continuous improvement in regulatory processes, ensuring efficiency, accuracy, and compliance.
- Mentor and guide junior regulatory staff to enhance team capability and performance.
- Uphold the highest standards of integrity, compliance, and ethical conduct in all regulatory activities.
Qualifications & Requirements
Education & Certifications
- Bachelor’s degree in pharmacy (mandatory).
- Advanced degrees or certifications in Regulatory Affairs, Life Sciences, or related fields are highly desirable.
- Professional training in regulatory strategy, submissions, or compliance is considered a plus.
- Fluency in English (both written and spoken) is required.
Experience
- Minimum 5 years of hands-on experience in Regulatory Affairs within the pharmaceutical industry.
- Proven experience managing regulatory submissions and interactions with health authorities in Egypt.
- Strong knowledge of EDA regulatory guidelines and local regulatory requirements.
- Demonstrated ability to manage multiple projects, deadlines, and complex dossiers.
- Experience in multinational pharmaceutical companies is an advantage.
Skills & Competencies
- Regulatory Expertise: Deep understanding of regulatory frameworks, submission requirements, and product lifecycle management.
- Strategic Thinking: Ability to develop and execute regulatory strategies aligned with business goals.
- Project Management: Strong skills in planning, prioritization, and execution of regulatory projects.
- Analytical Skills: Ability to assess regulatory risks, interpret guidelines, and provide actionable recommendations.
- Cross-functional Collaboration: Effective in working with Medical, Quality, Marketing, and Supply Chain teams.
- Communication & Influence: Excellent technical writing, documentation, presentation, and stakeholder engagement skills.
- Results Orientation: Committed to delivering regulatory objectives with accuracy and timeliness.
- Integrity & Compliance: Upholds ethical standards and ensures adherence to regulatory requirements and company policies.
