Regulatory Affairs Specialist

Job Description 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 regi...