Responsible for managing advanced regulatory affairs, regulatory operations support, eCTD publishing / submission for US market and compliance activities to ensure adherence to global regulatory requirements, industry standards, and legal frameworks across product development and lifecycle stages. The role oversees preparation and review of regulatory submissions, technical dossiers, and compliance documentation required for product approvals and regulatory reporting. It contributes to monitoring regulatory developments, policy updates, and industry intelligence, evaluating their impact on regulatory strategies and product registration plans. The position supports preparation of regulatory applications, responses, and communications with health authorities. It also collaborates with cross-functional teams to strengthen regulatory documentation management, compliance monitoring, and regulatory strategy execution, enabling effective product approvals and sustained regulatory alignment.
Essential Functions:
- Oversee DMF compilation & review process activities
- Execute and review eCTD & electronic submissions across regions
- Ensure document version control & governance compliance
- Monitor regulatory intelligence and assess strategic impact