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Syed Sameer Email & Phone Number
Manager - Global Submission Management
at
Amgen India
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✓ Verified May 2026
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Current company
Role
Manager - Global Submission Management
Location
Hyderabad, Telangana, India
Company size
Who is Syed Sameer? Overview
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Quick answer
Syed Sameer is listed as Manager - Global Submission Management at Amgen India, a company with 545 employees, based in Hyderabad, Telangana, India. AeroLeads shows a matched LinkedIn profile for Syed Sameer.
Syed Sameer previously worked as General Manager - Regulatory Services at Accenture and Submission Specialist - Regulatory Operations at Accenture. Syed Sameer holds Master’S Degree, Pharmaceutics, A from Osmania University, Hyderabad.
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Email format at Amgen India
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Amgen India
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Profile bio
About Syed Sameer
Regulatory Affairs/Operations professional responsible for high quality dossier submissions in eCTD format to regulatory agencies resulting in drug approvals. Regulatory submission Specialist who supports multiple sponsors to compile and file major applications (INDs, NDAs, ANDAs, BLAs, MAAs, CTAs), life-cycle management activities, including post approval, for products across multiple therapeutic areas in US, Canada, EMA, GCC and other regions.Team Leader of the Service Solutions team which is responsible for all department staff augmentation projects and additional internal and external deliverables.Identify opportunities for automation within regulatory processes. Design and execute automation ideas using various tools that automatically test functionality. Run tests for databases, systems, networks, applications, hardware and software.Identifying opportunities to deliver practice offerings to clients. Experienced in Operational Excellence, Lean, Six Sigma, Process Excellence, Digital Transformation, Business Process Mapping, Continuous Improvement, etc.Expertise in eCTD submission tools (Insight Publisher, Lorenz Docubridge, View Point, ISI tool box, Evermap AutoBoomark plugin).
Listed skills include Regulatory Submissions, Regulatory Requirements, Regulatory Compliance, Adobe Acrobat, and 27 others.
Current workplace
Syed Sameer's current company
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Amgen India
5 roles
Syed Sameer work experience
A career timeline built from the work history available for this profile.
General Manager - Regulatory Services
CurrentAccountable for the production and dispatch of regulatory submissions that support the development, registration, and marketing of products for Accenture’s clients. Ensuring that the electronic submission output complies with regional and country specific regulatory requirements as well as internal quality standards. Make decisions when they must be made.
Sep 2022 - Present
Submission Specialist - Regulatory Operations
Oversees the management of numerous regulatory submission projects ensuring submissions are in compliance with global regulatory requirements and meet Submission timelines. As a Sr. Project coordinator responsible for original applications, life-cycle submissions, this includes annual reports, CMC supplements, labeling supplements, Advertising/Promotional.
Sep 2018 - Oct 2022
Analyst - Regulatory Operations
Coordinated multiple eCTD submissions including INDs, NDAs, ANDAs, and MAAs including original applications and maintenance submissions from project kick-off through submission to the agency.Prepares submissions for FDA drug approvals as well as various coordinates several projects, specializes in maintenance submissions, compliant with SOPs. Also.
Dec 2014 - Sep 2018
Associate - Regulatory Operations
Responsibilities consisted of coordinating multiple eCTD submissions, knowledge of the drug development life cycle, organization of folders/files needed to build electronic submissions, submission through the FDA Electronic Submission Gateway and creation of electronic media for client or submission deliverables. Executed document coordinator tasks while.
Aug 2013 - Dec 2014
5 education records
Syed Sameer education
Master’S Degree, Pharmaceutics, A
Post Graduate Diploma In Patents Law, Patents, A
Nalsar University Of Law, Hyderabad
Bachelor Of Pharmacy, Pharmaceutical Sciences, A
Intermediate, Bi.P.C, A
Narayana Junior College , Vijayawada
High School, High School/Secondary Diplomas And Certificates, 90
St.Alphonsus High School, Nalgonda
FAQ
Frequently asked questions about Syed Sameer
Quick answers generated from the profile data available on this page.
What company does Syed Sameer work for?
Syed Sameer works for Amgen India.
What is Syed Sameer's role at Amgen India?
Syed Sameer is listed as Manager - Global Submission Management at Amgen India.
Where is Syed Sameer based?
Syed Sameer is based in Hyderabad, Telangana, India while working with Amgen India.
What companies has Syed Sameer worked for?
Syed Sameer has worked for Amgen India and Accenture.
How can I contact Syed Sameer?
You can use AeroLeads to view verified contact signals for Syed Sameer at Amgen India, including work email, phone, and LinkedIn data when available.
What schools did Syed Sameer attend?
Syed Sameer holds Master’S Degree, Pharmaceutics, A from Osmania University, Hyderabad.
What skills is Syed Sameer known for?
Syed Sameer is listed with skills including Regulatory Submissions, Regulatory Requirements, Regulatory Compliance, Adobe Acrobat, Ectd, Nees, Spl, and Crf Design.
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