Regulatory Affairs Manager
23 hours ago
Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission timelines are met as per business needs and agency expectations. 3. Agency Engagement & Partner Coordination • Act as the primary point of contact for Health Authorities in these regions. • Lead technical and administrative discussions with regulatory agencies to facilitate approvals. • Collaborate with regional distributors/partners for local submissions and regulatory intelligence. 4. Lifecycle Management • Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting. • Ensure timely implementation of changes across the region. • Maintain up-to-date regulatory documentation and databases. 5. Compliance & Intelligence • Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars. • Provide periodic update on impact and compliance to regulatory head. • Support regulatory inspections as needed. 6. Cross-functional Collaboration • Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities. • Support business development activities, due diligence, and partnership evaluations for the region. Qualifications & Experience: • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus. • 12-15 years of experience in regulatory affairs in the pharmaceutical/biotech industry, at least 5 years’ experience in biosimilars is preferred. • Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines. • Experience with regulatory submissions in MENA and CIS countries is mandatory. • Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements. Required Skills & Competencies: • Strong project management and organizational skills. • Excellent written and verbal communication skills. • Strategic thinking with attention to detail. • Proactive, collaborative, and culturally aware. • Ability to manage multiple priorities in a fast-paced environment
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