Sujeet Kumar Mishra
Regulatory affairs
Shadnagar,TG
Summary
A Certified ISO 9001:2015 Lead Auditor (QMS) and seasoned Regulatory Affairs/Clinical Research Quality/ PV Professional with over 15 years of experience in with extensive project experience from concept to development. Talents include in-depth knowledge of current guidelines, GCP and PV auditing. Knowledge in Clinical Research and Pharmacovigilance auditing, creative thinker/problem solver, positive attitude providing solid academic credentials and cross functional experience in clinical project management, product knowledge, time management, organizational and process improvement. Good understanding of appropriate therapeutic indications in clinical trials. Ability to understand and extract information from medical records.
Experienced in monitoring and auditing clinical trial and pharmacovigilance in accordance with GCP and GVP and company SOP's, while ensuring integrity of the study data and following study timelines. Skills in applying applicable clinical research regulatory recruitments such as GCP, GVP and ICH guidelines. Having experience in Regulatory Affairs such as Dossier authoring, preparation, and review of Artworks (SmPC, PI, PIL and Labelling activities) as per Country/ Regional and Global (ROW) market. Clear awareness of diverse background, alert to widely varied patient needs and circumstances, collaborative team player, acting as key resource to colleagues and allied health professionals
Overview
16
16
years of professional experience
3
3
Certifications
4
4
Languages
Work History
Deputy Manager- Regulatory Affairs, Biologics
Hetero Biopharma Ltd
04.2023 - Current
- Authoring and reviewing regulatory dossier content for protein therapeutics, including Modules 2 (2.4-2.7), 4, and 5, in compliance with global regulatory requirements.
- Upgrading and harmonizing regulatory dossiers in alignment with the latest international guidelines and agency expectations.
- Managing end-to-end regulatory dossier submissions to various global and regional authorities, ensuring timely execution and high-quality deliverables.
- Reviewing pre-clinical protocols and reports; supporting submissions to RCGM for approvals related to genetically manipulated biopharmaceutical products.
- Conducting regulatory review of source documents, including clinical trial protocols and clinical study reports, to ensure completeness of the CTD.
- Preparing responses to regulatory queries across Pre-Clinical, Clinical, and Pharmacovigilance domains (Modules 2, 4, and 5) in collaboration with cross-functional teams.
- Authoring clinical and scientific documents for scientific meetings and regulatory submissions in accordance with local/global requirements.
- Coordinating with cross-functional teams to obtain updated and accurate documentation for ongoing regulatory activities.
- Preparing and updating SmPCs for country, regional, and global markets; ensuring consistency across product information materials.
- Overseeing Global and Regional Product Information (PI), including package inserts, prescribing information, and artworks; addressing consumer queries and contributing to PI-related decisions.
- Supporting Clinical/Pharmacovigilance teams in preparing and submitting PSURs and RMPs as required by regional and international regulatory authorities.
- Providing oversight for review of RMPs, PSURs, PSMF, and portfolio-wide changes impacting prescribing information.
- Maintaining internal databases for ongoing Pre-Clinical, Clinical, and Pharmacovigilance submissions and tracking clinical studies for biopharma products.
- Participating in and supporting regulatory inspections related to Pharmacovigilance activities.
- Conducting regulatory intelligence to support new product introductions and strategic portfolio expansion.
- Uploading and managing local regulatory documents on electronic regulatory portals (e.g., SUGAM).
- Reviewing blinding documents for blinded clinical studies to ensure regulatory compliance.
- Evaluating vendors involved in clinical trials to ensure adherence to regulatory and quality standards.
- Career Growth: Deputy Manager-Regulatory Affairs (Pre-Clinical/ Clinical/ Pharmacovigilance) | Apr'23 to Present
Deputy Manager- PV Quality
Wipro Ltd (Wipro Digital Operations & Platforms)
09.2021 - 04.2023
- Maintaining Weekly & Monthly reports of projects (ICSRs/ non-ICSR) deliverables and liaising meetings with clients.
- Ensure staff is trained and compliant to Standard Operating Procedures (SOPs), applicable regulations & guidelines.
- Monitoring of Deviations and CAPAs are shared with clients within stipulated time frame.
- Ensure project deliverables are meeting timelines other SLA as per the MSA (Master Service Agreements).
- Monitor and ensure all client audit requests and complaints are responded and resolved within time frame.
- Lead problem solving and resolution efforts to include risk management, contingencies and issues. Drive proactive strategy to mitigate risks.
- Identify, suggest and implement agreed process improvements.
- Conduct Internal (risk-based) Assessments of processes/ workflows/ tools for the project.
- Identify skill gaps in the teams and provide inputs to Training Team for specific trainings.
- Monitor and update QMS related activities with the system.
- Provide leadership in the implementation of quality initiatives and customer requests.
- Lead team performance through oversight of key performance metrics.
- Ensure all the relevant controlled documents and trackers are maintained up-to-date.
- Team handling, conducting periodic feedback sessions and annual appraisals.
- Reviewing team performance and providing timely feedback.
- Ensure that a positive, collaborative team environment is maintained within the team. Encourage, motivate and lead by example, provide coaching and mentoring for project team members.
- Vendor Management: Handling of the vendors as per the contracts. Periodic monitoring and auditing of the services being provided by the vendors.
- Career Growth: Deputy Manager-PV Quality | Sep'21 to Apr'23
- Role: Due to transition of PV business from Springer Nature to Wipro Ltd there is a change in my organization.
Team Lead-PV Quality
Springer Nature Group (Springer Nature Technology and Publishing Solutions Private Limited)
04.2021 - 09.2021
- Team handling, conducting periodic feedback sessions and annual appraisals.
- Maintaining Weekly & Monthly reports and liaising meeting with clients along with meetings.
- Ensure staff is trained and compliant to Standard Operating Procedures (SOPs), applicable regulations & guidelines.
- Monitoring of Deviation and CAPAs are shared with clients within stipulated time frame.
- Ensure project deliverables are meeting timelines other SLA.
- Lead problem solving and resolution efforts to include risk management, contingencies and issues. Drive proactive strategy to mitigate risks.
- Identify, suggest and implement agreed process improvements.
- Conduct Internal risk-based Assessments of processes / workflows/ tools for the project.
- Identify skill gaps in the teams and provide inputs to Training Team for specific trainings.
- Lead problem solving and resolution efforts to include risk management, contingencies and issues. Drive proactive strategy to mitigate risks.
- Provide leadership in the implementation of Quality initiatives and customer requests.
- Lead team performance through oversight of key performance metrics.
- Ensure that a positive, collaborative team environment is maintained within the team. encourage, motivate and lead by example, provide coaching and mentoring for project team members.
- Work towards resolving performance related and morale issues within teams.
- Ensure all the relevant controlled documents and trackers are maintained up-to-date.
- Ensure performance and efficiency of the team through the monitoring and ongoing mentoring.
- Reviewing team performance and providing timely feedback.
- Career Growth: Team Lead-PV Quality | Apr'21 to Sep'21
Freelancer (Senior Consultant)
Biointegrity Consulting
09.2020 - 03.2021
- Monitoring and Data Review of BA/BE studies, Patient-based BE studies and Clinical Trials studies.
- Qualification audits of BA/BE Centers and Clinical Trial sites.
- Evaluation of Protocol, ICF and its appendices.
- Maintain knowledge of Quality Management and QA services per GXP. Contains Auditing, Assessments and Gap analysis, Inspection support, process improvements and SOP development and Training.
- Strong knowledge of auditing experience spans across Data Management, Vendor assessments, Investigator site audits, Trial Master File.
- Responsible for reviewing and forwarding to QA and ensuring highlighted issues are documented, promptly addressed, including setting up corrective action plan, and assuming full ownership and control over the corrective action process
- Assisted the data management groups and the project team in the processing of all clinical data by ensuring the timely collection of other aspects of job-related responsibilities data and query resolution.
- Career Growth: Freelancer (Senior Consultant) | Sep'20 to Mar'21
Team Lead, Clinical Affairs
Stelis Biopharma Pvt LTD., (A STRIDES GROUP)
02.2020 - 08.2020
- Developed recruitment strategies and an enrollment plan with the investigator and site staff to meet recruitment goals in coordination with the SOP and GCP guidelines
- Monitor and provide site management oversight for assigned clinical trials according to ICH-GCP guidelines, FDA and EU regulations, protocol and sponsor SOPs.
- Responsible for planning and implementing all activities required to conduct and monitor the clinical studies and ensure that Protocol, SOPs, applicable Regulatory Guidelines, and GxP requirements are followed.
- Ensures that data are reviewed in a timely fashion and submitted to the QA and Regulatory Department as applicable.
- To monitor and finalize all the clinical study documents in eTMF (E.g., Wingspan) in consultation with Department Head.
- Work closely with Head of the Department in developing the Clinical Development strategy.
- Develop and/or provide input on study design and methodology for clinical trials required for the drug(s) under investigation and reports thereof.
- Plans and manages study site activities and provides ongoing updates of site status to management
- Oversee, develop, and manage CDM staff with the goal of maintaining quality processes and practices in the management of clinical research information
- Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Instructions (WIs).
- Work with Head-Clinical Affairs, Finance, Project Lead and other key stake members of the organization as well as external vendors to finalize the budget for outsourced activities.
- Career Growth: Team Lead, Clinical Affairs | Feb'20 to Aug'20
Clinical Quality Manager
Sun Pharmaceutical Industries Limited
04.2017 - 08.2019
- Involved into In-process/system/process-based audits/monitoring of the clinical phases of clinical studies conducted on healthy volunteers/patients.
- Responsible for Preparation, planning and conduction of audits of the clinical studies conducted on patients, outsourced and in-house volunteers as per protocol, regulatory guidelines and SOPs.
- Review and finalization of the clinical study protocols and its appendices.
- Career Growth: Clinical Quality Manager | Apr'17 to Aug'19
Senior Executive (GCP Auditor)
Sun Pharmaceutical Industries Limited
04.2016 - 04.2017
- Involved into In-process/system/process-based audits/monitoring of the clinical phases of clinical studies conducted on healthy volunteers/patients.
- Responsible for Preparation, planning and conduction of audits of the clinical studies conducted on patients, outsourced and in-house volunteers as per protocol, regulatory guidelines and SOPs.
- Review and finalization of the clinical study protocols and its appendices.
- Career Growth: Senior Executive (GCP Auditor) | Apr'16 to Apr'17
Officer (GCP Auditor)
Sun Pharmaceutical Industries Limited
09.2013 - 04.2016
- Involved into In-process/system/process-based audits/monitoring of the clinical phases of clinical studies conducted on healthy volunteers/patients.
- Responsible for Preparation, planning and conduction of audits of the clinical studies conducted on patients, outsourced and in-house volunteers as per protocol, regulatory guidelines and SOPs.
- Review and finalization of the clinical study protocols and its appendices.
- Career Growth: Officer (GCP Auditor) | Sep'13 to Apr'16
Clinical Research Executive
Lambda Therapeutic Research Limited
12.2009 - 08.2013
- Conduction and completion of BE studies in e-CRF and Phase-I trials.
- Conduction and completion of Phase trials in therapeutic areas such as- Anti- obesity (Phase-I), Type-II Diabetes (Phase-I), H1N1 vaccine trials (Phase-I, II & III).
- Active and remote monitoring and execution of BE studies.
- Coordination with monitors and sponsor’s representatives who visit for site and trial monitoring.
- Resolution of any Sponsor/Clients and regulatory queries related to clinical studies/trials.
- Supported various regulatory audits and audits by various sponsors.
- Team Management: Was leading, mentoring & monitoring the performance of the team to ensure efficiency in process operations & meeting of individual & group targets.
- Career Growth: Clinical Research Executive | Dec'09 to Aug'13
Education
Masters in Pharmacy - Pharmaceutical Biotechnology
BPUT
Rourkela, Odisha01.2008
Bachelor in Pharmacy - undefined
Sambalpur University/BPUT
Rourkela, Odisha01.2005
Skills
Clinical Research
Certification
Executive Programme for Young Professionals | General Management from IIMC, Kolkata | 2013
RESEARCH & PUBLICATIONS
- Release Kinetic Studies of Aspirin Microcapsules | Ethyl Cellulose, Cellulose Acetate Phthalate, and their Mixtures by Emulsion Solvent Evaporation Method’ published | Dec, 19th, 2009 in Scientia Pharmaceutica (Austria).
- Comparative study of extraction, purification and estimation of bromelain | Stem and Fruit of pineapple plant’ published | 2010(Vol. 34), Thai Journal of Pharmaceutical Sciences.
PREVIOUS EXPERIENCE
- Jun'08 to Aug'09: Kanak Manjari Institute of Pharmaceutical Sciences (KMIPS), Rourkela, Orissa | Lecturer, Department of Pharmaceutical Biotechnology
- Sep'05 to Sep'06: Glenmark Pharmaceuticals, Ankleshwar, Gujarat | Trainee, Quality Assurance (API)
PERSONAL DETAILS
- Date of Birth: 28th Aug 1982
- Nationality: Indian
- Languages: English, Hindi, Bengali and Gujarati.
- Address: Correspondence: C/O: Mahendra Goud, 1-20/4/1/A/1, Teacher’s Colony, Shahnagar, Telangana-509216
- Permanent: Sujeet Kumar Mishra, Flat No. A/403, Greenview Residency, Near Madhavnagar VUDA, Atladara Bil Road, Atladara, Vadodara, Gujarat-390012
Timeline
Deputy Manager- Regulatory Affairs, Biologics
Hetero Biopharma Ltd
04.2023 - Current
Deputy Manager- PV Quality
Wipro Ltd (Wipro Digital Operations & Platforms)
09.2021 - 04.2023
Team Lead-PV Quality
Springer Nature Group (Springer Nature Technology and Publishing Solutions Private Limited)
04.2021 - 09.2021
Freelancer (Senior Consultant)
Biointegrity Consulting
09.2020 - 03.2021
Team Lead, Clinical Affairs
Stelis Biopharma Pvt LTD., (A STRIDES GROUP)
02.2020 - 08.2020
Clinical Quality Manager
Sun Pharmaceutical Industries Limited
04.2017 - 08.2019
Senior Executive (GCP Auditor)
Sun Pharmaceutical Industries Limited
04.2016 - 04.2017
Officer (GCP Auditor)
Sun Pharmaceutical Industries Limited
09.2013 - 04.2016
Clinical Research Executive
Lambda Therapeutic Research Limited
12.2009 - 08.2013
Bachelor in Pharmacy - undefined
Sambalpur University/BPUT
Masters in Pharmacy - Pharmaceutical Biotechnology
BPUT