Summary
Overview
Work History
Education
Skills
Affiliations
Accomplishments
Certification
Languages
Work Availability
Timeline
Generic
Anish Chakravarthy

Anish Chakravarthy

2218, 12th Main A Block, Subramanya Nagar, 2nd Stage, Rajajinagar, Bengaluru

Summary

Dynamic regulatory professional with a PTI - Pharmaceutical Training International (CPD Certified) specialization in ANDA submissions. Over 12 years of experience in regulatory affairs for pharmaceutical products across global markets including US, EU, GCC, and ASEAN. Proven leadership in team coordination, strategic submissions, and maintaining strong relationships with regulatory authorities. Adept at handling complex variations and ensuring compliance with international guidelines.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Regulatory Affairs - Manager - FDF LATAM & MENA

XELLIA PHARMACEUTICALS PVT LTD
Bangalore
03.2020 - Current
  • Developed and implemented regulatory strategies to meet corporate objectives.
  • Researched information regarding competitor's product licenses and registrations in order to anticipate market entry strategies.
  • Reviewed promotional materials for accuracy prior to submission for approval by relevant regulatory bodies.
  • Collaborated with cross-functional teams such as quality assurance, manufacturing, engineering, legal, marketing, and sales on projects related to regulatory affairs initiatives.
  • Created and maintained regulatory databases for tracking submissions and approvals.
  • Managed the submission process of new products or changes to existing products through the appropriate national health authorities.
  • Prepared technical documentation packages for registration purposes worldwide.
  • Coordinated the preparation of responses to inquiries from regulatory authorities.
  • Conducted meetings with government agencies, industry associations, and other stakeholders to ensure compliance with applicable regulations.
  • Evaluated potential risks associated with new products or changes before submitting them for review by regulators.

Assistant Manager - Regulatory Affairs

XELLIA PHARMACEUTICALS PVT LTD
Bangalore
07.2014 - 03.2020
  • Advised senior management on legal aspects of business decisions and activities as they relate to regulatory matters.
  • Developed and implemented regulatory strategies to ensure compliance with applicable regulations.
  • Prepared responses to inquiries from federal, state, and local agencies regarding regulatory issues.
  • Collaborated with external stakeholders including vendors, customers, suppliers, consultants, and attorneys in order to ensure compliance with applicable laws and regulations.
  • Worked closely with Quality Assurance department personnel in order to develop systems that promote product quality control while adhering to all relevant regulation standards.

Regulatory Affairs – Executive

BAL PHARMA LIMITED
Bangalore
06.2012 - 05.2014
  • Generated concise reports that effectively outline progress made towards achieving organizational goals and objectives.
  • Organized and facilitated regular meetings with senior management teams.
  • Established relationships with key partners and vendors to ensure successful project outcomes.
  • Coordinated cross-functional teams to deliver high quality results within tight timelines.
  • Used strong issue resolution and communication skills to cultivate and strengthen lasting client relationships.

Jr. Officer - Regulatory Affairs

INTEGRATED GLOBAL REGULATORY SERVICES
Bangalore
11.2010 - 05.2012
  • Maintained databases of clients, vendors, suppliers.
  • Participated in internal audits to evaluate efficiency of processes.
  • Updated and maintained CRM database information on customers to track interactions and insights.
  • Led crisis management efforts to resolve issues promptly and efficiently.
  • Enforced compliance with regulatory standards and company policies.

Education

Master of Science - Biochemistry

GKISM College
Bangalore
09-2010

Bachelor of Science - Biotechnology

SSMRV Degree College
Bangalore
07-2008

Skills

  • Error-free dossiers preparation
  • Strong knowledge of regulatory guidelines (US, EU, GCC, ASEAN)
  • Effective problem-solving abilities
  • Territory management in global markets
  • Proficient in Amplexor tools
  • Project management skills
  • Experience in consulting with regulatory authorities
  • Expertise in variation submissions
  • Proven leadership in team environments

Affiliations

  • Maintaining health and work balance by trekking, swimming and regular exercises at gym
  • Being student of science, I love plants and flowers and hence frequently spend my time in gardening.
  • Employee of the Year Award from Integrated Global Regulatory Services

Accomplishments

  • Product approval obtained after being rejected by KSA authority within review cycle period by discussing and explaining the product information for review and consideration.
  • Registered pharmaceutical drug products with query free in Bahrain.

Certification

  • PTI – Pharmaceutical Training International (CPD, UK Certified) – ANDA submissions.
  • IAHS, India – Protein related works

Languages

Telugu
First Language
Kannada
Proficient (C2)
C2
English
Proficient (C2)
C2
Danish
Beginner
A1
Croatian
Beginner
A1
Hindi
Proficient (C2)
C2
German
Beginner
A1

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Regulatory Affairs - Manager - FDF LATAM & MENA

XELLIA PHARMACEUTICALS PVT LTD
03.2020 - Current

Assistant Manager - Regulatory Affairs

XELLIA PHARMACEUTICALS PVT LTD
07.2014 - 03.2020

Regulatory Affairs – Executive

BAL PHARMA LIMITED
06.2012 - 05.2014

Jr. Officer - Regulatory Affairs

INTEGRATED GLOBAL REGULATORY SERVICES
11.2010 - 05.2012

Master of Science - Biochemistry

GKISM College

Bachelor of Science - Biotechnology

SSMRV Degree College

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Anish Chakravarthy