Franchise Lead Regulatory Affairs, Global Drug Development India
Current
May 2023 - Present
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Jitendra Patel Email & Phone Number
Franchise Lead Regulatory Affairs @ Novartis(Ex- Roche, Bayer & Eisai) | Innovative medicines, Biologics, Gene therapy, Complex generics | Regulatory strategy | Regulatory compliance & LCM
at
Novartis India
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✓ Verified May 2026
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Profile completeness 86%
Current company
Role
Franchise Lead Regulatory Affairs @ Novartis(Ex- Roche, Bayer & Eisai) | Innovative medicines, Biologics, Gene therapy, Complex generics | Regulatory strategy | Regulatory compliance & LCM
Location
Mumbai, Maharashtra, India
Company size
Who is Jitendra Patel? Overview
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Jitendra Patel is listed as Franchise Lead Regulatory Affairs @ Novartis(Ex- Roche, Bayer & Eisai) | Innovative medicines, Biologics, Gene therapy, Complex generics | Regulatory strategy | Regulatory compliance & LCM at Novartis India, a company with 832 employees, based in Mumbai, Maharashtra, India. AeroLeads shows a matched LinkedIn profile for Jitendra Patel.
Jitendra Patel previously worked as Franchise Lead Regulatory Affairs, Global Drug Development India at Novartis India and Sr. Manager Regulatory Affairs - Global Drug Development India at Novartis India. Jitendra Patel holds Masters Of Pharmacy, Pharmaceutics, Distinction from Rajiv Gandhi University Of Health Sciences.
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Novartis India
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Profile bio
About Jitendra Patel
Regulatory Affairs professional with post-graduation (M.Pharm) in Pharmaceutics and having 16 years of experience in innovative medicines, biologics and complex generics. Rich and diverse experience of developing and implementing regulatory strategies, managing submissions for new products & global clinical trials, life cycle management & regulatory compliance, and regulatory due diligence for in-licensing & out licensing. Added experience of managing complex regulatory projects involving mergers and spin-offs. Exposure to regulatory policy re-forms initiatives through industry associations. Distinction of having experience in both core Pharmaceuticals and Bio-pharmaceuticals organizations.Key expertise include:- Developing and implementing Regulatory strategy, managing submissions for launch of new products (NCE, biologics & gene therapy).- Life cycle maintenance of small molecules and large molecules (including biologicals, monoclonal antibodies, r-DNA products).- Regulatory intelligence, insights & analysis on competitive landscapes - Effective Planner for regulatory submissions & projects and have managed submissions for India (DCGI, CDSCO), US, EU and ROW markets. - Regulatory due diligence of CMOs - Dexterous in Medical Writing skills.- Exposed to corporate projects which include product development from concept phase to development and implementation at pilot & commercial scale.- Managing clinical trials applications (CTA) for Phase- 2 & Phase-3 global trials (GCT) & Phase-4 trials including post CT approval compliance.- Well conversant with Intellectual Property Rights concepts.Specialties: Regulatory affairs, Scientific content writing, regulatory compliances
Current workplace
Jitendra Patel's current company
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Novartis India
8 roles
Jitendra Patel work experience
A career timeline built from the work history available for this profile.
Sr. Manager Regulatory Affairs - Global Drug Development India
Feb 2022 - Jun 2023
Regulatory Affairs Manager
Jan 2020 - Feb 2022
Senior Manger - Regulatory Affairs
- Working closely with commercial, medical, and RA stakeholders for regulatory activities including submissions & regulatory strategies.- Ensuring regulatory licenses to operate through full level of compliance by timely renewal & managing post-approval variations- Providing proactive regulatory partnership to commercial teams to support regional and.
Jun 2016 - Dec 2019
Manager - Regulatory Affairs And Quality Assurance
- Planning and managing submissions for DCGI, India for in-licensing of Drug products and Medical devices in Indian market.- Delivering submissions for NDA/ Clinical trials, Registration certificate, Import license, Repacking permission and Test license.- Preparation of documents for Clinical trial application (CTA).- Managing Corporate Quality Assurance.
Apr 2013 - May 2016
Executive- Regulatory Affairs
-Compilation of e-CTD submissions for US, Europe and Australia.-Managing submissions for new ANDAs and post approval changes submissions for US market.-Delivering submissions for MHRA,UK and EU-DCP products including variations for appropriate life cycle management of the products.-Providing inputs for continuous improvements of Quality documents.-Handling.
May 2012 - Apr 2013
Executive- Regulatory Affairs
- Planning and delivering regulatory submissions for DCGI, India and ROW market.- Full operational knowledge for regulatory approval procedures of DCGI, India.- Delivering ANDA submissions and handling tactical activities for ANDA formulation development.-Planning and managing regulatory activities for Semi Regulated markets.
Jun 2010 - May 2012
Officer-Scientific Affairs
-Dual functions of regulatory affairs as well as project management for new product development and scale up.-patent status search for territories and drafting the patent applications for conventional and modified release dosage forms.
Jan 2009 - May 2010
Team & coworkers
Colleagues at Novartis India
Other employees you can reach at novartis.in. View company contacts for 832 employees →
SA
Srikanth Ande
Colleague at Novartis India
India, India
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AM
Anoop Madhav Yeggina
Colleague at Novartis India
Hyderabad, Telangana, India, India
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DS
Disha Shetty
Colleague at Novartis India
Mangaluru, Karnataka, India, India
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VK
Vikram Katakam
Colleague at Novartis India
Hyderabad, Telangana, India, India
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MC
Mandar Chitnis
Colleague at Novartis India
Hyderabad, Telangana, India, India
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SS
Shrunga Shetty
Colleague at Novartis India
Udupi, Karnataka, India, India
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PI
Prerita Ingle
Colleague at Novartis India
Hyderabad, Telangana, India, India
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VT
Venkat Tumuluri
Colleague at Novartis India
Hyderabad, Telangana, India, India
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YS
Yeshpal Sharma
Colleague at Novartis India
Jalandhar, Punjab, India, India
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SK
Santhosh Kumar Kayithoj
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
Srikanth Ande
Colleague at Novartis India
India, India
View →
AM
Anoop Madhav Yeggina
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
DS
Disha Shetty
Colleague at Novartis India
Mangaluru, Karnataka, India, India
View →
VK
Vikram Katakam
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
MC
Mandar Chitnis
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
SS
Shrunga Shetty
Colleague at Novartis India
Udupi, Karnataka, India, India
View →
PI
Prerita Ingle
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
VT
Venkat Tumuluri
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
YS
Yeshpal Sharma
Colleague at Novartis India
Jalandhar, Punjab, India, India
View →
SK
Santhosh Kumar Kayithoj
Colleague at Novartis India
Hyderabad, Telangana, India, India
View →
4 education records
Jitendra Patel education
Masters Of Pharmacy, Pharmaceutics, Distinction
Pg Diploma In Medical & Scientific Writing, Medical Writing, 97
Cliniminds
General Course On Intellectual Property Dl101, Ipr
World Intellectual Property Organisation (Wipo)
Bachelor Of Pharmacy, Pharmacy
FAQ
Frequently asked questions about Jitendra Patel
Quick answers generated from the profile data available on this page.
What company does Jitendra Patel work for?
Jitendra Patel works for Novartis India.
What is Jitendra Patel's role at Novartis India?
Jitendra Patel is listed as Franchise Lead Regulatory Affairs @ Novartis(Ex- Roche, Bayer & Eisai) | Innovative medicines, Biologics, Gene therapy, Complex generics | Regulatory strategy | Regulatory compliance & LCM at Novartis India.
Where is Jitendra Patel based?
Jitendra Patel is based in Mumbai, Maharashtra, India while working with Novartis India.
What companies has Jitendra Patel worked for?
Jitendra Patel has worked for Novartis India, Roche, Bayer Pharmaceuticals Pvt. Ltd., Eisai Pharmaceuticals India, and Fdc Limited.
Who are Jitendra Patel's colleagues at Novartis India?
Jitendra Patel's colleagues at Novartis India include Srikanth Ande, Anoop Madhav Yeggina, Disha Shetty, Vikram Katakam, and Mandar Chitnis.
How can I contact Jitendra Patel?
You can use AeroLeads to view verified contact signals for Jitendra Patel at Novartis India, including work email, phone, and LinkedIn data when available.
What schools did Jitendra Patel attend?
Jitendra Patel holds Masters Of Pharmacy, Pharmaceutics, Distinction from Rajiv Gandhi University Of Health Sciences.
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