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 regula...