Manager - Global Regulatory Affairs Solutions (Gras)
Current
Jul 2024 - Present
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Dharmesh Soni Email & Phone Number
Manager - Global Regulatory Affairs Solutions (GRAS) at Syneos Health
at
Syneos Health
1 work email found
@syneoshealth.com
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✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
Manager - Global Regulatory Affairs Solutions (GRAS) at Syneos Health
Location
Gujarat, India, India
Company size
Who is Dharmesh Soni? Overview
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Quick answer
Dharmesh Soni is listed as Manager - Global Regulatory Affairs Solutions (GRAS) at Syneos Health at Syneos Health, a company with 16864 employees, based in Gujarat, India, India. AeroLeads shows a work email signal at syneoshealth.com and a matched LinkedIn profile for Dharmesh Soni.
Dharmesh Soni previously worked as Manager - Global Regulatory Affairs Solutions (GRAS) at Syneos Health and Senior Consultant - Global Regulatory Affairs Solutions (GRAS) at Syneos Health. Dharmesh Soni holds P.G. Diploma In Drug Regulatory Affairs (Formulation) from Institute Of Pharmaceutical Management.
Company email context
Email format at Syneos Health
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{first}.{last}@syneoshealth.com
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Profile bio
About Dharmesh Soni
A regulatory affairs professional with more than 12 years of work experience and with a strong academic background in Pharmaceuticals. Have hands on experience in preparation, review, submission of pre approval and post approval regulatory documents (parenteral and oral solid dosage forms). I am passionate about my profession as I get involved in process of bringing drugs to market available for public use.The following are my key strengths:1) Regulatory life cycle management which includes pre approval as well as post approval submissions to health authorities like US, EU, Other Advanced Markets and Emerging Markets2) eCTD compilation and publishing3) Expertise with Veeva, LIQUENT, ETQ Reliance, pharmaREADY, LORENZ eValidator, Harmony eLabel and SPL Xforms4) Regulatory compliance5) Corporate communication with clients as well as to health authorities representing company's internal procedures/processes6) Assessment of critical change control reportable to regulatory authority7) SOPs and Regulatory submissions database management8) Strategic regulatory consulting for timely product launches9) Project management skills for timely submission of dossiers10) Supporting other cross functional teams (Business Development, QA, Operations, etc.) for CMC, Regulatory and Quality related inquires
Listed skills include Anda, Pharmaceutical Industry, Pharmaceutical Research, Formulation, and 17 others.
Current workplace
Dharmesh Soni's current company
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Syneos Health
7 roles
Dharmesh Soni work experience
A career timeline built from the work history available for this profile.
Senior Consultant - Global Regulatory Affairs Solutions (Gras)
- Preparation of regulatory submissions for post approval maintenance activities in global markets
- Understand project budget, scope of projects, allocated hours, and tracks compliance
- Interact with internal and external personnel, clients, and technical experts on projects
- Arrange, lead, and report on client meetings
- Provide operational advice to clients
- Participate in quality improvement efforts to increase overall operational efficiency
Dec 2021 - Jun 2024
Sr. Executive - Regulatory Affairs (Us And Other Advanced Markets)
- Preparation, compilation and submission of eCTD NDA/ANDA/ANDS/DCP dossiers complying USFDA/HC/EU guidances and regulations
- Post approval submission and product life cycle management
- Responding to the queries received from USFDA/HC/EU
- Providing regular insights and regulatory strategies to different stake holders
- Expertise in reviewing, assessing, managing the documents needed for regulatory submissions
- Coordination with internal and external stakeholders for regulatory filing related documentation
Nov 2016 - Dec 2021
Executive - Regulatory Affairs (Us Market)
- Preparation, compilation and submission of eCTD ANDA dossiers complying USFDA guidance and regulations
- Post approval submission and product life cycle management
- Responding to the queries received from USFDA
- Expertise in reviewing, assessing, managing the documents needed for regulatory submissions
- Coordination with internal and external stakeholders for regulatory filing related documentation
Aug 2015 - Nov 2016
Executive - Ira (Regulated Markets)
- To ensure timelines are met for all project submissions including dossiers, query responses and all other regulatory applications
- Handling communications with company's associates, regulatory partners and regulatory assessors through emails and tele-conferences for the regulatory affairs point of view
- Support to Marketing and Business Development team
Mar 2015 - Aug 2015
Sr. Officer - Ira (Regulated Markets)
- Preparation, compilation and submission of dossiers to Regulatory Agencies
- Post approval submissions and product life cycles management of drug products
- Artworks (Label, Carton and Package Insert) review and approval
May 2014 - Feb 2015
Chemist-Ra/F&D
- Co-ordinate & follow up with QA, QC, Production & Packing department as well as API Manufacturers for collecting regulatory requirements for preparation of dossiers
- Compilation & dispatch of dossiers as well as samples as per country’s guideline
- To prepare lab scale batches of ophthalmic formulations, respiratory solutions and otic solutions
- To carry out Accelerated and Real time stability studies
- To fill the reports of stability studies, LSBR and to prepare stability summaries for regulatory submission
Aug 2012 - Apr 2014
Team & coworkers
Colleagues at Syneos Health
Other employees you can reach at syneoshealth.com. View company contacts for 16864 employees →
AK
Alok Kumar
Colleague at Syneos HealthLucknow, Uttar Pradesh, India, India
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DB
Diane Bruetsch
Colleague at Syneos HealthAnn Arbor, Michigan, United States, United States
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KT
Krisztina Tóth
Colleague at Syneos HealthHungary, Hungary
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YK
Yasmina Kannoue
Colleague at Syneos HealthSofia, Sofia City, Bulgaria, Bulgaria
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RR
Rahul Rahul
Colleague at Syneos HealthWest Delhi, Delhi, India, India
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ND
Nikki Di Franco
Colleague at Syneos HealthCleveland, Ohio, United States, United States
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MK
Mahnaaz Khatib
Colleague at Syneos HealthPune, Maharashtra, India, India
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AM
Amy Moore
Colleague at Syneos HealthCave Springs, Arkansas, United States, United States
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AM
Ayush Mehta
Colleague at Syneos HealthDelhi, India, India
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CD
C.W. Draper
Colleague at Syneos HealthChesterfield, Missouri, United States, United States
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Alok Kumar
Colleague at Syneos HealthLucknow, Uttar Pradesh, India, India
View →
DB
Diane Bruetsch
Colleague at Syneos HealthAnn Arbor, Michigan, United States, United States
View →
KT
Krisztina Tóth
Colleague at Syneos HealthHungary, Hungary
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YK
Yasmina Kannoue
Colleague at Syneos HealthSofia, Sofia City, Bulgaria, Bulgaria
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RR
Rahul Rahul
Colleague at Syneos HealthWest Delhi, Delhi, India, India
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ND
Nikki Di Franco
Colleague at Syneos HealthCleveland, Ohio, United States, United States
View →
MK
Mahnaaz Khatib
Colleague at Syneos HealthPune, Maharashtra, India, India
View →
AM
Amy Moore
Colleague at Syneos HealthCave Springs, Arkansas, United States, United States
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AM
Ayush Mehta
Colleague at Syneos HealthDelhi, India, India
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CD
C.W. Draper
Colleague at Syneos HealthChesterfield, Missouri, United States, United States
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4 education records
Dharmesh Soni education
P.G. Diploma In Drug Regulatory Affairs (Formulation)
Institute Of Pharmaceutical Management
P.G. Diploma In Patent Law
M.Pharm, Pharmaceutics
FAQ
Frequently asked questions about Dharmesh Soni
Quick answers generated from the profile data available on this page.
What company does Dharmesh Soni work for?
Dharmesh Soni works for Syneos Health.
What is Dharmesh Soni's role at Syneos Health?
Dharmesh Soni is listed as Manager - Global Regulatory Affairs Solutions (GRAS) at Syneos Health at Syneos Health.
What is Dharmesh Soni's email address?
AeroLeads has found 1 work email signal at @syneoshealth.com for Dharmesh Soni at Syneos Health.
Where is Dharmesh Soni based?
Dharmesh Soni is based in Gujarat, India, India while working with Syneos Health.
What companies has Dharmesh Soni worked for?
Dharmesh Soni has worked for Syneos Health, Sun Pharma, Cadila Pharmaceuticals Limited, Claris Lifesciences Limited, and Amanta Healthcare Ltd..
Who are Dharmesh Soni's colleagues at Syneos Health?
Dharmesh Soni's colleagues at Syneos Health include Alok Kumar, Diane Bruetsch, Krisztina Tóth, Yasmina Kannoue, and Rahul Rahul.
How can I contact Dharmesh Soni?
You can use AeroLeads to view verified contact signals for Dharmesh Soni at Syneos Health, including work email, phone, and LinkedIn data when available.
What schools did Dharmesh Soni attend?
Dharmesh Soni holds P.G. Diploma In Drug Regulatory Affairs (Formulation) from Institute Of Pharmaceutical Management.
What skills is Dharmesh Soni known for?
Dharmesh Soni is listed with skills including Anda, Pharmaceutical Industry, Pharmaceutical Research, Formulation, Pharmaceutics, Drug Delivery, Regulatory Affairs, and Dissolution.
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