DGMGM Regulatory Affairs (ROW Head)
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Job Location:
Monthly Salary:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Location: Hyderabad India
Department: Regulatory Affairs
Reporting to: MD
Experience: 15–25 years in Regulatory Affairs (Injectables ROW markets; strong exposure to 505(b)(2) preferred)
Role Summary
The Regulatory Affairs Head – ROW Market will be responsible for leading and managing all regulatory submissions approvals and compliance activities for Injectable products across Rest of World (ROW) markets. The role requires strong expertise in injectable dosage forms regulatory pathways and experience handling 505(b)(2) submissions. The incumbent will ensure timely product registrations lifecycle management regulatory intelligence and alignment with global regulatory strategies.
Key Responsibilities
1. Regulatory Strategy & Planning
Develop and execute regulatory strategies for injectable products intended for ROW markets.
Provide strategic guidance for 505(b)(2) projects including bridging strategies study requirements and regulatory risk assessment.
Work closely with R&D Formulation Analytical Clinical and Project Management teams to ensure regulatory expectations are built into development plans.
2. Dossier Preparation & Submission
Lead the preparation review and submission of CTD/eCTD dossiers for injectables (new submissions variations renewals).
Oversee creation of Module 1–5 for ROW submissions.
Ensure robust data package readiness (CMC non-clinical clinical) for 505(b)(2) filings.
3. Regulatory Interactions & Approvals
Coordinate with health authorities across Asia Africa LATAM CIS and Middle East regions.
Respond to regulatory queries within established timelines.
Facilitate audits and ensure compliance with market-specific requirements.
4. Compliance & Documentation
Ensure all regulatory dossiers and product labeling comply with local regulations and global quality standards.
Maintain regulatory databases track submissions and monitor approval timelines.
Oversee change control assessments and regulatory impact evaluations.
5. Cross-Functional Leadership
Lead a team of regulatory managers/executives.
Provide training mentorship and ensure continuous skill enhancement.
Collaborate with internal and external stakeholders including CROs partners and scientific consultants.
6. Regulatory Intelligence
Monitor global regulatory updates affecting injectables and 505(b)(2) pathways.
Assess impact of new guidelines and ensure proactive alignment.
Required Skills:
Regulatory affairs Injectable Row Market Injectable
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
