We are seeking a highly motivated and experienced International Registration Specialist to join our global regulatory affairs team. The successful candidate will be responsible for managing and executing product registration activities across various international markets, ensuring compliance with local and global regulatory requirements. This role involves comprehensive oversight of regulatory submissions, lifecycle management, and strategic input to expand our product presence worldwide.
- Prepare, compile, and submit high-quality regulatory dossiers (e.g., CTD/eCTD format) for new product registrations, variations, and renewals in international markets.
- Liaise effectively with global health authorities to respond to inquiries, address deficiencies, and facilitate timely approvals of product applications.
- Develop and implement international regulatory strategies to support product development and commercialization goals, considering regional specificities and timelines.
- Manage the entire product lifecycle from initial registration through post-market commitments, including variations, renewals, and product discontinuations.
- Monitor and interpret changes in international regulatory landscapes, assessing their impact on company products and operations, and communicating these insights to relevant stakeholders.
- Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing, Marketing, and Legal teams to gather necessary documentation and ensure alignment on regulatory submissions.
- Maintain accurate and up-to-date regulatory databases and tracking systems for all international registrations and submissions.
- Provide regulatory guidance and support for internal projects, due diligence activities, and product development initiatives targeting global markets.
- Participate in regulatory intelligence gathering and contribute to the continuous improvement of regulatory processes and procedures.
- Ensure all activities are conducted in compliance with internal SOPs, GxP regulations, and international regulatory guidelines.
