Manager - Regulatory Intelligence - Pharma

Role Overview:

The Regulatory Intelligence Manager will lead regulatory intelligence activities to support proactive compliance, strategic decision-making, and risk mitigation across global pharmaceutical markets.

Key Responsibilities:

- Monitor and analyze global regulatory updates impacting products and pipelines

- Conduct impact assessments of regulatory changes on ongoing and planned submissions

- Provide strategic regulatory insights to R&D, quality, and commercial teams

- Develop regulatory intelligence reports, dashboards, and executive summaries

- Support global product registration and lifecycle management strategies

- Liaise with regulatory authorities, industry bodies, and external consultants

- Ensure compliance with international regulatory frameworks (USFDA, EMA, CDSCO, etc.)

- Maintain regulatory databases and knowledge repositories

- Guide teams on evolving regulatory trends and policy shifts

Key Skills:

- Strong expertise in global pharmaceutical regulatory frameworks

- Experience in regulatory intelligence and compliance strategy

- Deep understanding of submission processes and product lifecycle regulations

- Analytical skills to interpret and assess regulatory changes

- Strong documentation and reporting capabilities

- Excellent cross-functional communication and influencing skills