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About the Role
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 appr...
- 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 appr...
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