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@zyduscadila.com
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Bharat Bhat is listed as Associate Director Regulatory Affairs at Teva Pharmaceuticals at Teva Pharmaceuticals, a company with 10 employees, based in Mumbai, Maharashtra, India. AeroLeads shows a work email signal at zyduscadila.com and a matched LinkedIn profile for Bharat Bhat.
Bharat Bhat previously worked as Associate Director at Teva Pharmaceuticals and Senior Manager Regulatory Affairs at Teva Pharmaceuticals.
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➢ Experience in Regulatory Affairs / CMC Writing / Regulatory submissions of Sterile dosage form such as injectable, ophthalmic, Synthetic Peptide Drug Products, complex injectable, drug-device combination products and OSD for USFDA/TPD in ICH CTD Module 1-5, ICH, eCTD and as per country specific requirements.➢ Comprehensive knowledge on regulatory requirements of Biosimilars and Interchangeable Biological Products and Human factors studies for device.➢ Strategy lead representing Regulatory on Product development team providing pre and post approval regulatory strategies.➢ Experience in resolving concerns raised by regulatory authorities by developing appropriate regulatory strategy and facilitating for successful commercial launch or maintaining business continuity.➢ Ability to work successfully with extended, cross functional project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
Listed skills include Validation, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, and 11 others.
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Maharashtra, India
Thrilled to announce my promotion to Associate Director. The journey has been incredible. Over the past year a new responsibilities has been added and no stone remains unturned to accomplish the goal.This promotion means more to me than the word can express. It's the culmination of years of dedication and hardship. I could not have achieved this without a.
Mumbai, Maharashtra, India
-Leading development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC requirements, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks for submission.-Responsible to execute regulatory.
Ahmedabad Area, India
-Experience in assembling injectable product dossiers for submission to USFDA.-Plan, coordinate, and write responses to deficiency from USFDA during their review of the submissions.-Responsibilities include Regulatory CMC strategy & risk assessment, preparation/review of high quality submissions, responses etc. for commercial product support (life-cycle.
Ahmedabad, Gujarat
ANDA submissions and Life cycle management of injectables,
Hyderabad Area, India
Responsible for the preparation, maintenance and timely completion of regulatory documents and preparation of eCTD module to support submissions to US FDA & TPD (Steriles).
India
Job Responsibilities:A) Activities related to Tech Transfer products:1. Reviewing the product book, Lab scale batches, analytical results, and discussion with Formulation Development for complete understanding of product and process. 2. Planning and execution of Scale-up batch, which also includes preparation of Manufacturing protocol and its online.
Other employees you can reach at tevapharm.com. View company contacts for 10 employees →
Kathy Speliotes
Colleague at Teva Pharmaceuticals
Littleton, Colorado, United States, United States
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KC
Kristian Ceratti
Colleague at Teva Pharmaceuticals
Italy, Italy
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RA
Rucsandra Ali
Colleague at Teva Pharmaceuticals
Bucharest Metropolitan Area, Romania
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HW
Hannah Wenborn
Colleague at Teva Pharmaceuticals
London Area, United Kingdom, United Kingdom
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KM
Karen Manske
Colleague at Teva Pharmaceuticals
Prairie Village, Kansas, United States, United States
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MC
Monte Chaddha
Colleague at Teva Pharmaceuticals
Amroha, Uttar Pradesh, India, India
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KF
Katharina Feist
Colleague at Teva Pharmaceuticals
Ulm, Baden-Württemberg, Germany, Germany
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DO
Dijana Ostojic
Colleague at Teva Pharmaceuticals
Croatia, Croatia
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NN
Nina Neboga
Colleague at Teva Pharmaceuticals
Almaty, Kazakhstan, Kazakhstan
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EA
Eric Avshalomov
Colleague at Teva Pharmaceuticals
Israel, Israel
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Quick answers generated from the profile data available on this page.
Bharat Bhat works for Teva Pharmaceuticals.
Bharat Bhat is listed as Associate Director Regulatory Affairs at Teva Pharmaceuticals at Teva Pharmaceuticals.
AeroLeads has found 1 work email signal at @zyduscadila.com for Bharat Bhat at Teva Pharmaceuticals.
Bharat Bhat is based in Mumbai, Maharashtra, India while working with Teva Pharmaceuticals.
Bharat Bhat has worked for Teva Pharmaceuticals, Cipla, Zydus Group, Sun Pharma, and Mylan.
Bharat Bhat's colleagues at Teva Pharmaceuticals include Kathy Speliotes, Kristian Ceratti, Rucsandra Ali, Hannah Wenborn, and Karen Manske.
You can use AeroLeads to view verified contact signals for Bharat Bhat at Teva Pharmaceuticals, including work email, phone, and LinkedIn data when available.
Bharat Bhat is listed with skills including Validation, Regulatory Affairs, Pharmaceutical Industry, Technology Transfer, Gmp, U.S. Food And Drug Administration, Fda, and Generic Programming.
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