Please complete the CAPTCHA to continue
@sandoz.com
✓
LinkedIn matched
A concise factual answer block for searchers comparing this professional profile.
Ashokkumar Suthar is listed as Sr Manager, Global Regulatory Affairs | Technical Writing | Strategic CMC Expertise | Amendment & Lifecycle Management | Control Strategy | Global Submission & Deficiencies | RA Compliance | Ex-Amneal, Ex-Zydan, Ex-Cipla based in Bengaluru, Karnataka, India. AeroLeads shows a work email signal at sandoz.com and a matched LinkedIn profile for Ashokkumar Suthar.
Ashokkumar Suthar previously worked as Senior Manager at Micro Labs Limited and Manager at Micro Labs Limited. Ashokkumar Suthar holds Master'S Degree, Pharmaceutical Sciences, First Class, Distinction from Lachoo Memorial College Of Science & Tech.
This section adds company-level context without repeating Ashokkumar Suthar's masked contact details.
AeroLeads found 1 current-domain work email signal for Ashokkumar Suthar. Compare company email patterns before reaching out.
A seasoned Regulatory Affairs professional with over 14 years of expertise, specializing in global regulatory affairs, submission & life-cycle management, drug master file reviews, strategic regulatory planning and audit support.Adept in CMC review, minimizing critical deficiencies, crafting quality responses to agencies, and leading teams with precision to achieve management goals.Demonstrate extensive knowledge of Regulatory Guidelines, ensuring meticulous adherence to filings in diverse markets and aligning products with market requirements.Exhibit strong cross-functional coordination skills, liaising seamlessly with R&D, product development, and operation/quality functions for prompt and accurate documentation.Sound knowledge of Analytical, Quality Assurance, Formulation Processes, US FDA’s GDUFA processes and electronic activities, and Technology Transfer activities.An effective communicator skilled in relationship management, with analytical prowess, a detail-oriented approach, and a flexible attitude.
Listed skills include Regulatory Affairs, Fda, Anda, Qbd, and 32 others.
A career timeline built from the work history available for this profile.
Bengaluru, Karnataka, India
- Steer error-free regulatory submissions through meticulous checks, overseeing US, US-PEPFAR and WHO, covering OSD and Sterile formulation. Manage and facilitate amendments and post-approval variations- Ensured 95% compliance rate with zero errors in global markets by overseeing and executing timely submission of 15 regulatory filings- Increased.
Mumbai, Maharashtra, India
- Managed Post-Approvals: Ensured zero defects in global regulatory affairs by managing variations and annual reports for US, EU, RoW countries, aligning with business priorities.- Regulatory Assessments: Conducted evaluations of change controls and regulatory assessments using system software for global regulatory markets.- Collaboration with QC & R&D.
Mumbai, Maharashtra, India
- Demonstrated expertise in managing post-approval regulatory activities and addressing ANDA deficiencies- Orchestrated seamless coordination among internal and external stakeholders, ensuring smooth operations
Ahmedabad Area, India
- Technical Document Review: Expertly reviewed documents and compiled 505(b)(2) NDA / ANDAs (NCE-1, PIV, etc.) / Amendments in eCTD format, covering Topical and Solid Oral formulations.- Post-Approval Supplements: Compiled and reviewed supplements, including site transfers, PAS, CBE-30, and CBE-0, along with annual reports for meticulous documentation..
Kalwe, Navi Mumbai
- Managed regulatory submissions and addressed deficiencies in multiple regions (US, EU, CA, JP, Africa, etc)- Handled post-approval variations and maintained documentation for the product life-cycle- Evaluated change controls for regulatory compliance post-approval.- Coordinated cross-functional responses to regulatory defi ciency letters.- Maintained.
Ahmedabad, Gujarat, India
- Prepared and compiled ANDA submissions in eCTD format, focusing on solid oral dose forms for the US market.- Reviewed documents from ARD, QA, QC, and R&D to ensure accurate submission packages.- Developed product labels and patient information leaflets for clear communication and regulatory adherence.- Facilitated cross-departmental communication to.
Quick answers generated from the profile data available on this page.
Ashokkumar Suthar is listed as Sr Manager, Global Regulatory Affairs | Technical Writing | Strategic CMC Expertise | Amendment & Lifecycle Management | Control Strategy | Global Submission & Deficiencies | RA Compliance | Ex-Amneal, Ex-Zydan, Ex-Cipla.
AeroLeads has found 1 work email signal at @sandoz.com for Ashokkumar Suthar.
Ashokkumar Suthar is based in Bengaluru, Karnataka, India.
Ashokkumar Suthar has worked for Micro Labs Limited, Cipla, Usv Private Limited, Zydus Cadila, and Sandoz.
You can use AeroLeads to view verified contact signals for Ashokkumar Suthar, including work email, phone, and LinkedIn data when available.
Ashokkumar Suthar holds Master'S Degree, Pharmaceutical Sciences, First Class, Distinction from Lachoo Memorial College Of Science & Tech.
Ashokkumar Suthar is listed with skills including Regulatory Affairs, Fda, Anda, Qbd, Ectd, Regulatory Requirements, Change Control, and Sop.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contactsCheck these profiles if this is not the Ashokkumar Suthar you were looking for.
View similar profiles
