Regulatory Affairs Manager

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 an...