Ramesh Kuruva

About Ramesh Kuruva

With around 11 years in the pharmaceutical regulatory field, my expertise lies in spearheading global regulatory strategies for pharmaceutical products including Oncological medicines and Drug-Device combinations. My responsibilities aligns with fulfilling patient\'s demand through regulatory filing efficiently, and I bring a wealth of experience in project management, stakeholder engagement, managing marketing authorization applications, clinical line extensions, labelling strategies, authoring PBRER/ACO, management of safety signal notifications, life-cycle maintenance of drug products. At AstraZeneca, my role not only involves regulatory strategy and execution but also building the capabilities of our global regulatory team, ensuring compliance and efficiency in our operations. In my current position as a Regulatory Affairs Manager II, I\'ve been instrumental in the strategy, planning, and execution of Product Registrations (MAA)s, line extension submissions for antibody drug conjugation-biological products. Leveraging tools like Veeva Vault, CARA (RIMS), understanding of global regulatory requirements across all regions and maintenance process, experience with regulatory submissions, eCTD format. I\'ve guided cross-regional teams through complex regulatory landscapes, ensuring successful submissions, label updates that adhere to various health authority requirements and successful launch of product for the first time in market (as part of Global Operations Launch Team). My commitment to process improvement and life-cycle maintenance continues to support AstraZeneca\'s global regulatory strategy team.As part of my new responsibilities assigned, started working on Clinical Trial Application submissions for Phase studies, CTA maintenance, CRO studies, DSUR and PSLLs.

Experience

1. Associate Regulatory Affairs Director i

   AstraZeneca

   Apr 2025 — Present · Bengaluru, IN

Education

• Al-Ameen College of Pharmacy, RGUHS, Bangalore

  M.Pharm Postgraduation, Clinical Pharmacy, Therapeutics, & Pharmacology

  2010 — 2012

• Bharath Institute of Pharmacy, Hyderabad, JNTU

  B.Pharm Undergraduation, Pharmacy

  2006 — 2010

Skills

• Validation
• Pharmaceutics
• Food Safety and Standards Act, 2006.
• Microsoft Office
• Pharmaceutical Industry
• Adverse Drug Reaction Monitoring
• Medication Chart Review
• Regulatory Affairs
• Patient Counseling
• Glp
• Adverse Event Reporting
• Answering to Drug Information Queries
• Case Studies
• Ms Office
• Clinical Research
• Clinical Pharmacology
• Gcp
• Ich-Gcp
• Drugs and Cosmetics Act, 1940
• Written & Oral Presentation Skills
• Biotechnology
• Pharmacology
• Gmp