10 years
0 Lacs
Posted:6 days ago|
Platform:
On-site
Full Time
As Director of Regulatory Research & Intelligence, you will lead and develop a team of research consultants responsible for regulatory intelligence, compliance support, and advisory services for clients across the pharmaceutical and medical device sectors. You will ensure delivery excellence, quality control, and strategic insight, serving as the senior-most authority for regulatory research activities in India. You will interface directly with global clients, executive stakeholders, and cross-regional project leads.
· Team Leadership: Build, mentor, and oversee a multidisciplinary team of research consultants; set performance targets and foster professional development.
· Quality Oversight: Ensure that all research, analysis, and regulatory intelligence delivered by the India team meets Kamet’s global quality and compliance standards.
· Strategic Research Direction: Define and evolve the group’s research agenda in alignment with emerging regulatory trends (FDA, EMA, CDSCO, TGA, etc.) and client priorities.
· Project Delivery: Oversee the execution of complex regulatory intelligence projects, ensuring on-time and in-scope delivery.
· Stakeholder Communication: Present complex regulatory insights, implications, and recommendations clearly and persuasively to executive audiences, both written and verbal, in English.
· Cross-Functional Alignment: Collaborate with consultants and subject matter experts in regulatory affairs, clinical, quality, supply chain, labeling, and M&A.
· Risk Management: Identify and mitigate regulatory and reputational risks for client organizations.
· Continuous Improvement: Implement best practices, tools, and methodologies to enhance team capability and operational efficiency.
· Education: Advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field. PhD or MBA preferred. RAC or equivalent certification is a plus.
· Experience: 10+ years in regulatory affairs, regulatory intelligence, or compliance within pharma/medical devices; at least 5 years in consulting, including direct client-facing roles and team management.
· Leadership: Demonstrated track record of leading research or regulatory teams (preferably in an international or cross-functional environment).
· Regulatory Depth: Expert knowledge of global and Indian regulatory frameworks (FDA, EMA, CDSCO, WHO, ICH, etc.), GMP/GCP/QMS.
· Communication: Exceptional verbal and written English skills; able to convey nuanced regulatory insights to senior stakeholders and non-experts alike.
· Project Management: Experience overseeing multiple concurrent projects and managing project managers/consultants.
· Analytical Skills: Advanced research, data analysis, and reporting capabilities, including proficiency in regulatory databases and business tools (Excel, PowerPoint, relevant software).
· Entrepreneurial Mindset: Ability to drive innovation, efficiency, and value in a rapidly evolving regulatory landscape.
· Well-read on regulatory and scientific literature; ability to synthesize new research and guide the team on best practices.
· Culturally adept, able to operate and lead in global teams.
· High ethical standards and a passion for quality in research and client service.
Kamet Consulting Group is a Life Sciences Management Consulting firm providing Strategic Advisory, Implementation, Capability Building, and Outsourced Services to Pharmaceuticals, Medical Devices, Digital Health, and Consumer Health companies across their value chain. We are an equal opportunity employer. All qualified applicants are encouraged to apply.
Kamet Consulting Group
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