Krishnananda Nayak
A dynamic, strategic, forward-looking executive with a passion for strong leadership.
- Role
- Sr Manager - Regulatory, Quality & Pharmacovigilance at Novo Nordisk
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Krishnananda Nayak
PROFESSIONAL SUMMARY 23+ years of experience managing quality assurance…
Experience
Sr Manager - Regulatory, Quality & Pharmacovigilance
Apr 2012 — Present · Dubai, AE
Managed regulatory submissions operations for 49 countries in Africa, India, Sri Lanka, Bangladesh, Nepal and Bhutan.Managed regulatory process governance, implemented strategies, provided regulatory support to internal and external stakeholders and ensured information flow within affiliate, business area and HQ in line with company priorities and business needs.Secured health authority approvals from 11 countries in Africa for new products in the area of diabetes, growth hormone, obesity, hemostasis to achieve regulatory business targets.Finalized the regulatory strategy and execute the project for new product registration across 26 countries in Africa in compliance with relevant internal and regulatory guidelines.Increased patient access to Modern Insulin devices across >26 countries in Africa by obtaining registration.Implemented French English packaging across 22 francophone countries, country specific packaging for 10 anglophone countries and Portuguese packaging for 4 countries in Africa. Collaborated with various units of Indian Health Authority, HQ regulatory and quality teams for establishing the ‘National Reference Standard for ‘human Insulin’, ‘insulin aspart’ and Implemented in Indian Pharmacopoeia.Ensured strategic health authority engagement, personally interacted with the regulatory authorities for in India, Nigeria, Ethiopia, Uganda Mauritius, Botswana, Namibia and Senegal for strengthening relationship, trust, understand the requirements and upcoming changes.Designated Quality Responsible Person (QRP) and Qualified Person for Pharmacovigilance (QPPV) for responsible to ensure compliance to the legal obligations of Quality Assurance, Pharmacovigilance and drug safety monitoring.Leading a high performance team of Regulatory, Quality and Pharmacovigilance professionals.
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