Manikandan M
Chennai
Summary
Accomplished Regulatory affairs with 5.8 years of experience, a solid history of achievement, and an extensive list of skills acquired over the years. Experienced in supporting a wide portfolio of pharmaceutical products for all markets. Track record of achieving exceptional results in supporting the launch of new products to market and in the life-cycle management of on-market products.
Overview
7
7
years of professional experience
Work History
Senior Regulatory Associate – I
Navitas Lifesciences Pvt. LTD
04.2024 - Current
- Managed submissions for EME, Serbian, and central Balkan clusters, including Initial MAA, NDA, and Renewal Variations.
- Compiled dossiers adhering to country-specific requirements and guidelines.
- Oversaw coordination and timely delivery of major growth and post-approval lifecycle dossiers to stakeholders under strict constraints.
- Ensured compliance with eCTD and eSUB formats for all submissions.
- Developed NeeS packages and delivered submissions in collaboration with Country Regional Strategists and CMC strategists by due dates.
- Acted as SME by monitoring submissions, assigning tasks, and providing team support.
Regulatory Associate
Navitas Lifesciences
04.2022 - 03.2024
- Executed end-to-end dossier preparation and publishing for BNT-19 submissions.
- Ensured high-quality output delivered on time through a 'right first time' approach.
- Served as primary Regulatory Operations liaison between CMC and publishing teams.
- Generated metrics while maintaining reliability to prevent overdue dispatches.
- Analyzed complex information and communicated effectively with Regulatory Affairs leads.
- Adapted to ensure timely submissions amidst fluctuating workloads.
- Negotiated timelines during workload conflicts to maintain submission schedules.
- Managed CMC Change Management projects, collaborating with strategists and Hub Submission Managers.
Junior Regulatory Associate
Navitas Lifesciences
04.2021 - 03.2022
- Hub Submission manager for EME Market Primarily working for Serbian and Balkan Cluster in EME region
- Responsible for the managing submission of various clients with daily deliverables
- Providing a Regulatory Affairs support during internal and external clients
- Collaborate with various departments for the planning, preparation, and quality control checks of submissions Analyze and identify regulatory requirements and ensure the submissions are agency compliant Accurate Interpretation of the guidelines issued by ICH, US-FDA, EMEA and various Regulatory Agencies
Regulatory Associate Trainee
Navitas Lifesciences
11.2018 - 03.2020
- Understand the requirements of various regulatory submissions such as IND, ANDA, NDA and DMF in CTD/eCTD formats for various regulatory agencies such as US-FDA and EU Utilization of current publishing technologies to assemble and publish dossiers according to regulatory requirements Document level publishing which includes bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines Adherence to appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements Regularly update and maintain regulatory submissions database & maintain archives.
Education
BSc - Zoology and Biotechnology
Loyola College
01.2017
Higher secondary education -
Madras Christian college higher secondary School
01.2014
Secondary education -
Bethany higher secondary School
01.2012
Skills
- Leadership and organization
- Problem solving
- Adaptability
- Work ethic
- Continuous learning
Domainexpertise
- Complete idea on EME (Europe, the Middle East) submissions and publishing requirements.
- High Technical knowledge on NeeS, eSub, eSubmitter, and Paper publishing procedures and issue rectification.
- Document authoring, Document verification and Versioning.
- Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate.
Achievements and recognitions
- Got 'OUTSTANDING PERFORMANCE AWARD' in Navitas Several Times.
- Got many emails appreciations from direct clients and Submission leads as well.
Applicationsandtools
- Liquent Insight / CALYX
- GDMS
- Lorenz eValidator
- Adobe Professional
- Office 365
- ALBIH NeeS Checker
- I-Plan
- Compass SCC
- Citrix
- SA & P Production
Mobileno
+91 8939122493, +91 8610387574
Personal Information
- Father's Name: Murugan S
- Date of Birth: 11/11/95
- Gender: Male
- Nationality: Indian
Languages
- Tamil
- English
Disclaimer
I hereby declare that information given above is accurate and true to the best of my knowledge. However, I will be glad to provide further information, if needed.
Sincerely Yours,
MANIKANDAN M
Timeline
Senior Regulatory Associate – I
Navitas Lifesciences Pvt. LTD
04.2024 - Current
Regulatory Associate
Navitas Lifesciences
04.2022 - 03.2024
Junior Regulatory Associate
Navitas Lifesciences
04.2021 - 03.2022
Regulatory Associate Trainee
Navitas Lifesciences
11.2018 - 03.2020
BSc - Zoology and Biotechnology
Loyola College
Higher secondary education -
Madras Christian college higher secondary School
Secondary education -
Bethany higher secondary School
Similar Profiles
Surendra RawatSurendra Rawat
Student Recruitment Manager at Navitas Eduservices Pvt LtdStudent Recruitment Manager at Navitas Eduservices Pvt Ltd
SOUNDARYA PSOUNDARYA P
JUNIOR REGULATORY ASSOCIATE at Navitas Life Sciences Pvt Ltd.JUNIOR REGULATORY ASSOCIATE at Navitas Life Sciences Pvt Ltd.
SUPUN SANAKA LIYANA ARACHCHISUPUN SANAKA LIYANA ARACHCHI
Assistant Civi Engineer at Navitas Solar pvt(ltd)Assistant Civi Engineer at Navitas Solar pvt(ltd)
Zaheer Syed.SZaheer Syed.S
Team Manager at GSR Global ServicesTeam Manager at GSR Global Services
PIYUSH RANJAN DASPIYUSH RANJAN DAS
Associate at BNY IndiaAssociate at BNY India