Associate, Regional Regulatory Affairs

Job Description1. 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.
- Coll...