Key Responsibilities:
- trategic Regulatory Leadership: Develop and implement robust regulatory strategies for new product introductions, lifecycle management, and market expansion, aligning with Soficopharm's strategic goals
- Dossier Preparation and Submission: Lead the preparation, review, and submission of high-quality regulatory dossiers (in CTD/eCTD format) for product registration, re-registration, and variations to the EDA and other relevant regulatory authorities for export markets . This is a critical function requiring a deep understanding of EDA guidelines, including those for pricing, bioequivalence, stability studies, and variations .
- Export Regulatory Affairs: Manage and coordinate regulatory documentation for export dossiers to various countries, ensuring compliance with different regional formats (CTD, eCTD, Technical) . Handle all export-related regulatory activities to support the company's expansion into new international markets .
- Lifecycle Management: Proactively manage product lifecycle activities, including renewals, variations, line extensions, and label updates to maintain compliant product registrations across all markets .
- Health Authority Liaison: Act as the primary point of contact with the Egyptian Drug Authority (EDA) and other international regulatory bodies, managing all communications, addressing inquiries, and driving submissions to a successful approval .
- Regulatory Intelligence: Monitor and interpret changes in local and international regulatory legislation, assessing their impact on the company's products, processes, and business operations . Provide guidance and implement necessary actions to maintain compliance.
- Cross-Functional Collaboration: Provide expert regulatory guidance to internal stakeholders, including R&D, Quality, Marketing, Commercial, and Supply Chain teams . Participate in project teams to ensure regulatory requirements are met from development through to commercialization and post-market activities .
- Documentation and Compliance: Maintain meticulous regulatory documentation and databases, ensuring all records are in line with internal SOPs and external regulatory requirements . Review and approve labeling, promotional content, and artwork to ensure regulatory compliance .
- Post-Market Surveillance: Support post-market surveillance activities and ensure compliance with regulations concerning product recalls, rapid alerts, and market monitoring as per EDA guidelines .
Qualifications and Requirements:
- Education: Bachelor's degree in Pharmaceutical Sciences (Pharmacy) is a must .
- Experience: Minimum of 2-6 years of relevant experience in a Regulatory Affairs role within the pharmaceutical industry, specifically in Egypt .
What We Offer:
- An opportunity to work with a leading and pioneering pharmaceutical company in Egypt.
- A dynamic and challenging role with significant impact on the company's growth.
- Exposure to a wide variety of products and international regulatory environments.
- Competitive salary and benefits package, including medical and social insurance
