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Vamshi Krushna Veldanid Regulatory Affairs Expert
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I will teach fundamentals of drug regulatory affairs. I will guide students provide support beginner, mid level job seekers and make them experts in DRA filed.
Exam and presentations will conduct biweekly on DRA topics,
Furthermore provide Soft Skills development course as well.
Teaching style: Online with PPT.
Methodology: Topic Discussions. Q&A.
Engaging session.
Interview preparation
Resume writing
CL preparation
Interview Q&A
Biweekly feedback
Soft Skills:
Body language
Communication Skills
Teamwork
Strength Assessment
Mentoring on weekends
Email writing
Conflicts resolution
Certification Courses:
RAPS
Certifications
USFDA
EMA
LATAM
APAC
ROW
Other certified courses:Your Guide to the Pharmaceutical Industry.
• VEEVA VAULT certifications
• Drug Regulatory Pathways, Data and Market Exclusivity US and AU.
• FDA Generic Drugs Overview, Abbreviated New Drug Review Process.
• Introduction to FDA Human Drug Review and Approval Basics.
• FDA Role of Office of New Drugs. The New Drug Review Process. Biologics Review. Pediatric Regulations.
• Communication Foundations.
• Effective Listening.
• Communicating with confidence.
• RAPS European Council (REC): Peer insights on Remote Audits and the Regulatory Professional of the Future.
• FDA REdI Annual Conference 2020.
• An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs –General Considerations Webinar.
• Building Business Relationship & Building Trust
• How to win Trust & connect Masterfully
• Interpersonal Communication & Learning to be approachable
• Communicating Across Culture Virtually & Building Resilience
• Aligning Your Values with Work, Life and Everything in Between
Exam and presentations will conduct biweekly on DRA topics,
Furthermore provide Soft Skills development course as well.
Teaching style: Online with PPT.
Methodology: Topic Discussions. Q&A.
Engaging session.
Interview preparation
Resume writing
CL preparation
Interview Q&A
Biweekly feedback
Soft Skills:
Body language
Communication Skills
Teamwork
Strength Assessment
Mentoring on weekends
Email writing
Conflicts resolution
Certification Courses:
RAPS
Certifications
USFDA
EMA
LATAM
APAC
ROW
Other certified courses:Your Guide to the Pharmaceutical Industry.
• VEEVA VAULT certifications
• Drug Regulatory Pathways, Data and Market Exclusivity US and AU.
• FDA Generic Drugs Overview, Abbreviated New Drug Review Process.
• Introduction to FDA Human Drug Review and Approval Basics.
• FDA Role of Office of New Drugs. The New Drug Review Process. Biologics Review. Pediatric Regulations.
• Communication Foundations.
• Effective Listening.
• Communicating with confidence.
• RAPS European Council (REC): Peer insights on Remote Audits and the Regulatory Professional of the Future.
• FDA REdI Annual Conference 2020.
• An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs –General Considerations Webinar.
• Building Business Relationship & Building Trust
• How to win Trust & connect Masterfully
• Interpersonal Communication & Learning to be approachable
• Communicating Across Culture Virtually & Building Resilience
• Aligning Your Values with Work, Life and Everything in Between
Subjects
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Drug Regulatory Affairs Beginner-Expert
Experience
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RA expert (Oct, 2020–Present) at Merck Life Science
DRA end to end submission support.
Education
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Pharmaceutics (Nov, 2012–Dec, 2014) from KU–scored 78
Fee details
₹3,500–5,500/hour (US$41.27–64.85/hour)
Fee details will discuss further.
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Electronic City, Bengaluru, Karnataka, India
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Can travel:
No
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- Last login: Sep 14
- Registered: Apr 23
- Total Teaching exp: 8.0 yrs.
- Teaches online: Yes
- Online Teaching exp: 5.0 yrs.
- Teaches at student's home: No
- Homework Help: Yes
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Gender: Male
- Works as: Individual teacher
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Fee:₹3,500–5,500/hour(USD 41.27–64.85/hour)
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