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:

Senior Executive, Regulatory Affairs