Suneetha Dayaka
Hyderabad
Summary
Results-driven Regulatory Affairs leader with 20 years of experience in the pharmaceutical industry, specializing in drug substances CMC (DMFs, NDAs, ANDAs) from development to global filings. Adept at strategic regulatory planning, team leadership, and cross-functional collaboration, with expertise in handling complex molecules and ensuring timely regulatory submissions across global markets.
Overview
20
20
years of professional experience
Work History
General Manager - Drug Regulatory Affairs
Matrix Pharma Corp Private Limited
Hyderabad
2024.06 - Current
- Developed CMC strategies and resolved regulatory issues, facilitating effective R&D collaboration.
- Managed project workflows and prioritized submissions to achieve critical submission deadlines.
- Directed team on project timelines, ensuring timely regulatory submissions to meet compliance standards.
Deputy General Manager - Drug Regulatory Affairs
Mylan Laboratories Limited
Hyderabad
2008.03 - 2024.05
- Led lifecycle CMC management and submissions for markets including USFDA, EMA, TGA, EDQM, China, Brazil, Korea, Japan and WHO.
- Delivered global regulatory documentation, balancing strategies and timely filings.
- Executed drug establishment registration, drug listing, drug amount reporting, and SPOR data management to ensure regulatory compliance.
- Submitted sterile API documentation to regulatory agencies for compliance.
- Managed complex molecules including peptides, iron complexes, polymers, and cocrystals to support product development.
- Oversaw employee performance, fostered cross-functional relationships, and mentored team members to enhance team collaboration.
Executive - Corporate Regulatory Affairs
Aurobindo Pharma Limited
Hyderabad
2006.12 - 2008.03
- Coordinated regulatory filings and collaborated with internal teams to ensure timely submissions.
- Led cross-functional teams to develop strategic initiatives and enhance operational efficiency.
- Oversaw compliance with industry regulations and company policies in pharmaceutical operations.
- Managed communication between departments to ensure alignment on project goals and objectives.
Trainee Officer - Corporate Quality Assurance & Regulatory Affairs
Sai Advantium Pharma Limited
Hyderabad
2006.02 - 2006.12
- Coordinated quality assurance and regulatory documentation processes to maintain compliance with industry standards.
Education
M.Sc. - Biotechnology
Bharathidasan University
Tamil NaduSkills
- Strategic Regulatory Leadership
- Regulatory Filing Expertise
- Problem-Solving and Compliance Management
- Cross-Functional Team Collaboration
- Risk Assessment
- Quality Assurance Knowledge
- Project Prioritization and Change Management
- Regulatory compliance
Personal Information
- Date of Birth: 01/20/82
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Leadership And Impact
- Led high-performing teams, fostering collaboration across affiliates and internal departments.
- Anticipated regulatory challenges, driving proactive compliance and efficient submissions.
- Balanced global strategies with regional regulatory requirements to streamline processes.
Education And Achievements
- M.Sc. in Biotechnology, Bharathidasan University, Tamil Nadu, University Third Rank
- Undergraduate, J.M.J. College, Nagarjuna University, Silver Medalist, Awarded for papers on Industrial Waste Treatment and DNA Microarrays at national and state-level seminars.
Timeline
General Manager - Drug Regulatory Affairs
Matrix Pharma Corp Private Limited
2024.06 - Current
Deputy General Manager - Drug Regulatory Affairs
Mylan Laboratories Limited
2008.03 - 2024.05
Executive - Corporate Regulatory Affairs
Aurobindo Pharma Limited
2006.12 - 2008.03
Trainee Officer - Corporate Quality Assurance & Regulatory Affairs
Sai Advantium Pharma Limited
2006.02 - 2006.12
M.Sc. - Biotechnology
Bharathidasan University