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 Jul 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 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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Email format at Novartis India
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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 country level business priorities.- Collaborating with local, regional & global stakeholders for regulatory activities & projects.- Lead and manage FDA and CDTL liaising.- Supporting local & global assessments for established products. - Collaborating with commercial and strategy team to identify new launch/extension opportunities.
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 functions such as batch release, change controls, deviations, cGMP audits of CMO and suppliers and artworks approval.- Coordinating with CROs for planning of local clinical trials.
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 change controls.
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 →
DJ
Dr. Jyoti Juneja Matta
Colleague at Novartis IndiaDelhi, India
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NK
Neetu Kuntay
Colleague at Novartis IndiaHyderabad, Telangana, India
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SU
Sreshta Upparahal
Colleague at Novartis IndiaHyderabad, Telangana, India
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AS
Amar Sharma
Colleague at Novartis IndiaMathura, Uttar Pradesh, India
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VT
Varun Thakur
Colleague at Novartis IndiaHyderabad, Telangana, India
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CP
Chinmaya Pradhan
Colleague at Novartis IndiaHyderabad, Telangana, India
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SB
Showri Babu Chava
Colleague at Novartis IndiaHyderabad, Telangana, India
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PY
Pradeepkumar Yadav
Colleague at Novartis IndiaMohanlal Ganj, Uttar Pradesh, India
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KP
Kanhaiyalal Patidar
Colleague at Novartis IndiaSecunderābād, Telangana, India
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LS
Lokesh Sharma
Colleague at Novartis IndiaJaipur, Rajasthan, India
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Dr. Jyoti Juneja Matta
Colleague at Novartis IndiaDelhi, India
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NK
Neetu Kuntay
Colleague at Novartis IndiaHyderabad, Telangana, India
View →
SU
Sreshta Upparahal
Colleague at Novartis IndiaHyderabad, Telangana, India
View →
AS
Amar Sharma
Colleague at Novartis IndiaMathura, Uttar Pradesh, India
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VT
Varun Thakur
Colleague at Novartis IndiaHyderabad, Telangana, India
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CP
Chinmaya Pradhan
Colleague at Novartis IndiaHyderabad, Telangana, India
View →
SB
Showri Babu Chava
Colleague at Novartis IndiaHyderabad, Telangana, India
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PY
Pradeepkumar Yadav
Colleague at Novartis IndiaMohanlal Ganj, Uttar Pradesh, India
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KP
Kanhaiyalal Patidar
Colleague at Novartis IndiaSecunderābād, Telangana, India
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LS
Lokesh Sharma
Colleague at Novartis IndiaJaipur, Rajasthan, India
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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 Dr. Jyoti Juneja Matta, Neetu Kuntay, Sreshta Upparahal, Amar Sharma, and Varun Thakur.
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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