Senior Regulatory Intelligence Professional

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title:
Regulatory Intelligence Senior Manager

Key Responsibilities:
(1) Contribute to the monitoring, analysis, and reporting of global regulatory developments to support timely and compliant product submissions.
(2) Deliver high-quality regulatory intelligence outputs such as summaries of country-specific requirements, impact assessments, and recommendations on filing strategies.
(3) Oversee regulatory intelligence tools, databases, and processes to ensure effective monitoring, analysis, and communication.
(4) Maintain and improve regulatory monitoring systems and evaluate automation or outsourcing opportunities to enhance operational efficiency.
(5) Analyze global regulatory trends to identify cross-market submission requirements and provide strategic input for globally aligned dossier content and filing approaches.
(6) Anticipate and help manage major impending regulatory changes by supporting business readiness initiatives and contributing to enterprise regulatory change management projects.
(7) Build trusted partnerships with Global and Local Regulatory Affairs, Regulatory CMC, Policy teams, and other internal stakeholders to integrate intelligence into regulatory strategy.
(8) Lead or coordinate cross-product regulatory projects and ensure intelligence outputs are actionable and contribute to harmonized global strategies.
(9) Work closely with policy and strategy teams to align intelligence activities with business priorities and advocate for harmonization where needed.
(10) Track progress on intelligence workplans and contribute to the continuous improvement of tools, methodologies, and workflows.
(11) Propose enhancements to regulatory knowledge capture, sharing mechanisms, and content automation strategies.
(12) Participate in lessons-learned reviews and contribute to SOP or template updates supporting intelligence operations.

Qualifications & Skills:
1. Deep understanding of global regulatory frameworks and agency expectations across major and emerging markets.
2. Proven experience with global regulatory submissions and a strong ability to interpret and synthesize regulatory guidance and requirements.
3. Skilled in regulatory analysis, filing strategy development, and cross-market impact assessments.
4. Strong project management capabilities to drive multiple intelligence deliverables and regulatory initiatives in parallel.
5. Excellent verbal and written communication skills, with the ability to influence cross-functional teams and senior stakeholders without direct authority.
6. Experience managing regulatory tools and databases, with an interest in improving systems and applying automation or AI capabilities where feasible.
7. Understanding of knowledge management and change management principles in a regulatory context.

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