Regulatory Affairs Manager

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 admi...