Kavi Priya
Regulatory affairs associate
Hosur,TN
Summary
Dynamic Regulatory Affairs Associate with three years at Syneos Health (inVentiv) adept at managing regulatory submissions and ensuring global compliance. Proven ability to enhance document accuracy and streamline processes, showcasing strong communication and leadership skills. Expert in electronic common technical documents and compliance monitoring, driving project success through effective collaboration.
Overview
3
3
years of professional experience
1
1
Certification
2
2
Languages
Work History
Regulatory Affairs Associate
Syneos Health (inVentiv)
09.2022 - Current
- Prioritized project-related tasks to efficiently complete essential tasks.
- Managed post-approval changes, ensuring all necessary documentation was submitted accurately and on time.
- Maintained and archived regulatory submissions.
- Prepared and submitted regulatory file applications and supporting documentation.
- Enhanced regulatory compliance by meticulously reviewing and editing submission documents.
- Provided regional expertise and leading regulatory CTA.
- Submissions for client projects.
- Provide regulatory consultation for in-house clinical projects or standalone regulatory projects.
- Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations, including those regarding submissions.
- Compile, submit, and maintain regulatory submissions.
- Act as a liaison between regulatory agencies and external clients.
- Interact with external regulatory groups and regulatory agencies.
- Identify, communicate, and participate in the review of relevant regulatory guidance and current regulations.
- Provide regulatory strategy input to the project team and external clients.
- Has good skills in Veeva RIMS, lifecycle management, maintenance of registration records, creation of master records, and has hands-on experience of 3 years in the same.
Education
Bachelor of Pharmacy -
Karpagam University
Coimbatore, India 04.2001 -
High School Diploma -
Parimalam Matriculation Higher Secondary School
Hosur 04.2001 -
High School Diploma -
Parimalam Matricualtion Higher Secondary School
Hosur, India 04.2001 -
Skills
Compliance monitoring
Regulatory submissions
ICH guidelines
Submission preparation
License renewals
Technical documentation
Teamwork and collaboration
Time management
Leadership skills
Multitasking Abilities
Document preparation
Adaptability and flexibility
Effective communication
Certification
[Functional Department], [Mylan Laboratories] - [20 days]
Timeline
Regulatory Affairs Associate
Syneos Health (inVentiv)
09.2022 - Current
Bachelor of Pharmacy -
Karpagam University
04.2001 -
High School Diploma -
Parimalam Matriculation Higher Secondary School
04.2001 -
High School Diploma -
Parimalam Matricualtion Higher Secondary School
04.2001 -