Description
JOB DESCRIPTION
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 efficient 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
- Drive regulatory & supplement reporting activities
- Coordinate regulatory & health authority management interactions
- Support inspection readiness for DMF and regulatory audits
- Apply risk identification & mitigation across regulatory activities
- Ensure sustained regulatory compliance across product lifecycle
- Support quality & audit readiness initiatives
- PDF processing as per US eCTD specifications
- QC checks of submission components before publishing
- Adherence to SOPs, publishing checklists, and quality standards
Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses: 
