Naveen Kumar B
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Naveen Kumar B Email & Phone Number

Regulatory Manager (CMC) at CONTINUUM India LLP
Location: Bengaluru, Karnataka, India 6 work roles 2 schools
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Current company
CONTINUUM India LLP
Role
Regulatory Manager (CMC)
Location
Bengaluru, Karnataka, India
Company size
21 employees

Who is Naveen Kumar B? Overview

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Quick answer

Naveen Kumar B is listed as Regulatory Manager (CMC) at CONTINUUM India LLP, a with 21 employees, based in Bengaluru, Karnataka, India. AeroLeads shows a matched LinkedIn profile for Naveen Kumar B.

Naveen Kumar B previously worked as Senior Regulatory Consultant at Continuum India Llp and Senior Regulatory Affairs Associate at Navitas Life Sciences. Naveen Kumar B holds Master Of Pharmacy - Mpharm, Pharmacology from Rajiv Gandhi University Of Health Sciences.

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CONTINUUM India LLP

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About Naveen Kumar B

Regulatory Dossier compilation in ICH CTD format for EU countries. Well experienced in DCP / MRP / National Filings. Evaluated the queries rose by EU regulatory authorities / customers and prepared response for those queries. Filled many Variations (Type IA, IB, and II) .Reviewing the filled dossiers and compiling the re-registration of the same dossiers to file to other country / customer. Ensuring the life cycle of the product by adding the complete details of a product in RPIS (Regulatory Product Information System).Filed Renewals and Annual reports.

Current workplace

Naveen Kumar B's current company

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CONTINUUM India LLP
Continuum India Llp
Regulatory Manager (CMC)
chandigarh, chandigarh, india
Website
continuumindia.com
Employees
21
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6 roles

Naveen Kumar B work experience

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Regulatory Affairs

Parexel

Bengaluru Area, India

8

Mar 2015 - Oct 2019

Senior Regulatory Affairs Associate

Parexel

Banagalore

• Authoring and/or coordinating CMC activities for post approval changes, renewals, annual reports to meet filing requirements. Coordinating & contributing to responses to queries and performing quality review of regulatory CMC submissions.• Author global post approval submissions across different regions (EU, US, LATAM, AFME) identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability.• Collaborate with different teams (Analytical, Manufacturing, QA, CMOs) during the authoring and review of regulatory submissions to ensure compliance, scientific excellence, accuracy, and completeness.• Technical review of module 3 documents including specifications, analytical methods, method validation/verification/transfer reports, certificate of analysis (COA), batch records, impurity justifications, stability data/trends, stability protocol, product development report.• Author and review module 2 QOS and module 3 sections for all marketing approvals applications and post marketing applications.• Co-ordinated with sourcing department for vendor selection for excipients and drugs substances. Reviewed open part of drug substance DMF.• Prepare Cover Letter Application Forms and All M1 documents for EU National / DCP and MRP procedures.• Experience with TrackWise for change control management.• Perform gap analysis for dossier alignment projects.• Strong software troubleshooting skills highly desirable and experience with many client regulatory tools like GDMS, CARA, Insight Publisher (IP), Track-wise, Viva-volt, IRIS, Verity (ERIMS)• Prepared CPID for CANADA and CPD for Australia• Prepared Annual reports and PATE forms for Brazil Markets

Mar 2015 - Oct 2019

Regulatory Affairs Associate

Biocon

Bengaluru, Karnataka, India

Oct 2014 - Feb 2015
Team & coworkers

Colleagues at CONTINUUM India LLP

Other employees you can reach at continuumindia.com. View company contacts for 21 employees →

MR Mohd Rihan Raza Mohd Rihan Raza Colleague at Continuum India LlpChandigarh, India View → AK Aanchal Kochhar Aanchal Kochhar Colleague at Continuum India LlpChandigarh, India View → SS Sahila Saini Sahila Saini Colleague at Continuum India LlpChandigarh, India View → SC Simerjeet Chahal Simerjeet Chahal Colleague at Continuum India LlpIndia View → AJ Anna Jain Anna Jain Colleague at Continuum India LlpMandi, Himachal Pradesh, India View → SK Swaran Kohli Swaran Kohli Colleague at Continuum India LlpChandigarh, India View → SS Shivani Shukla Shivani Shukla Colleague at Continuum India LlpChandigarh, India View → DR Dr.Aditya Rana Dr.Aditya Rana Colleague at Continuum India LlpPanchkula, Haryana, India View → SS Swati Sharma Swati Sharma Colleague at Continuum India LlpChandigarh, India View → DP Dr Parnika Goyal Phd Dr Parnika Goyal Phd Colleague at Continuum India LlpChandigarh, India View →
2 education records

Naveen Kumar B education

Master Of Pharmacy - Mpharm, Pharmacology

Rajiv Gandhi University Of Health Sciences

Education record

Anitha Convent
FAQ

Frequently asked questions about Naveen Kumar B

Quick answers generated from the profile data available on this page.

What company does Naveen Kumar B work for?

Naveen Kumar B works for CONTINUUM India LLP.

What is Naveen Kumar B's role at CONTINUUM India LLP?

Naveen Kumar B is listed as Regulatory Manager (CMC) at CONTINUUM India LLP.

Where is Naveen Kumar B based?

Naveen Kumar B is based in Bengaluru, Karnataka, India while working with CONTINUUM India LLP.

What companies has Naveen Kumar B worked for?

Naveen Kumar B has worked for Continuum India Llp, Navitas Life Sciences, Parexel, and Biocon.

Who are Naveen Kumar B's colleagues at CONTINUUM India LLP?

Naveen Kumar B's colleagues at CONTINUUM India LLP include Mohd Rihan Raza, Aanchal Kochhar, Sahila Saini, Simerjeet Chahal, and Anna Jain.

How can I contact Naveen Kumar B?

You can use AeroLeads to view verified contact signals for Naveen Kumar B at CONTINUUM India LLP, including work email, phone, and LinkedIn data when available.

What schools did Naveen Kumar B attend?

Naveen Kumar B holds Master Of Pharmacy - Mpharm, Pharmacology from Rajiv Gandhi University Of Health Sciences.

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