About This Role
This role involves developing and implementing regulatory strategies for biosimilar product registrations across the Middle East, North Africa, CIS, and Non-EEA countries. It suits a regulatory affairs professional with a strong understanding of biosimilar pathways and experience with regional submissions.
Responsibilities
- 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
- 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
- Act as the primary point of contact for Health Authorities in these regions
- Lead technical and administrative discussions with regulatory agencies to facilitate approvals
- Collaborate with regional distributors/partners for local submissions and regulatory intelligence
- Manage post-approval changes (variations), renewals, labelling updates, and compliance reporting
- Ensure timely implementation of changes across the region
- Maintain up-to-date regulatory documentation and databases
- Monitor and interpret regional regulatory guidelines, regulations, and policies relevant to biosimilars
- Provide periodic update on impact and compliance to regulatory head
- Support regulatory inspections as needed
- Work with QA, QC, SCM, PM, Clinical, Commercial, and BD teams to align regulatory priorities
- Support business development activities, due diligence, and partnership evaluations for the region
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field
- Experience in regulatory affairs in the pharmaceutical/biotech industry
- Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines
- Experience with regulatory submissions in MENA and CIS countries is mandatory
- Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements
- Strong project management and organizational skills
- Excellent written and verbal communication skills
- Strategic thinking with attention to detail
- Proactive, collaborative, and culturally aware
