MOHAMMED SHOAIB MALIK
Submission Documentation Specialist
Hyderabad,TG
Work Preference
Summary
With six years of experience in regulatory publishing, I possess expertise in utilizing CARA and Veeva Vault for the creation and management of regulatory submissions. My background includes a strong focus on quality control of regulatory documents, ensuring submission readiness and compliance. Core Competencies: Project Management |Prompt Engineering (GenAI) | eCTD/Life Cycle Management || Publishing Tools: Cara, Veeva, Lorenz eValidator, ISI Toolbox, Share point.
Overview
6
6
years of professional experience
1
1
Language
Work History
Submission Documentation Specialist
Bristol Myers Squibb
09.2023 - Current
- I actively contribute to the management and publication of critical clinical and regulatory documents. This involves.
- Collaborating with global teams and external partners to structure and populate the Content Authoring and Review Application (CARA) system, ensuring protocols Clinical Study Reports, Investigator's Brochures, local Risk Management Plans, Original Protocols/Protocol Amendments, PBRER, DSUR, Protocol administrative letters and financial disclosures and submission documents are effectively published.
- Providing expert guidance and troubleshooting support to both internal (Global Scientific and Regulatory Documentation - GSRD) and external authors on various essential processes and tools. This includes assistance with PRISM/CARA, Core Templates, submission-readiness formatting, publishing procedures, and related workflows.
- Supporting cross-functional business partners by assisting them with the formatting and publishing of Source Requirement Checklists (SRCs) for protocols and submission-related documents.
- Streamlining the document submission process by remediating externally authored Word files to guarantee they meet submission standards and by efficiently managing PRISM import and publishing workflows.
- Facilitating the collection and review of important non-data-driven appendices for International Council for Harmonisation (ICH) Clinical Study Reports (CSRs).
- Partnering with cross-functional teams to clearly define the requirements for submission-ready externally authored regulatory documents.
- Contributing directly to the creation and management of key documents by participating in the coordination, compilation, and sometimes even the authoring of select protocol and submission documents.
- Document-level publishing to make documents submission ready as per the submission standards by creating internal and external links using the pdf tools in the published output. (e.g., bookmarking, linking, PDF version, Optimization etc.
- Performing quality checks on submissions for adherence to publishing requirements - communicating with authors/editors/reviewers for any missing material where necessary by email/chat.
- Maintaining accurate and detailed records of document preparation activities, including documenting changes, revisions, and approvals made during submission-related processes
Associate Regulatory Analyst
MAKRO CARE CLINICAL RESEARCH, Hyderabad
07.2022 - 08.2023
- Knowledge in understanding module wise documents for effective submission.
- Ability to co-ordinate and execute regulatory strategy for given project/product.
- Ability to identify the gaps in source documents before processing for submission.
- Experience in authoring and reviewing of document level publishing.
- Knowledge of filling the products in ECTD publishing tool.
- Authoring, uploading of documents through ECTD tool for effective submission.
- Excellent written and verbal communication skills for descriptive writing of chemistry manufacturing control documents.
- Perform the gap analysis of administrative and chemistry part of submission documents.
- Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
- Contribute to cross functional working groups as needed.
- In-house regulatory publishing and submission tools are AdobeAcrobat DC, Phlex pharma, Lorenz eValidator.
- Hands on experience Phlex pharma submission tool and Lorenz eValidator for document level publishing and submissions.
- Hands on expertise in EU and US submission from pre-approval to post approval activities Compilation of dossiers (Drug master files) and submitting to various regulatory agencies.
- Preparation of dossiers as per USFDA, EDQM, and other regulatory agencies dossier requirements.
- Preparation of responses to queries received from customers and regulatory agencies.
Associate Regulatory Publishing
DXC TECHNOLOGY, Hyderabad
03.2020 - 06.2022
- Hands-on-experience in publishing of electronic based regulatory documents of Clinical/non-clinical.
- In-house regulatory publishing and submission tools are ISI Toolbox/Publisher, TRS Publisher (PRISM), Adobe Acrobat DC, Lorenz eValidator.
- Responsible for end-to-end publishing activities and assisted regulatory support with the publishing, compilation and validation of regulatory documents including Annual Reports, DSUR, PSUR, PBRER, Clinical Protocols, Protocol Amendments, Statistical Analysis Plan, Clinical Study Reports (CSR), Bioanalytical Study Reports (BSR), Investigator Brochures (IB), Responses to agencies, Drug Safety Evaluation (DSE), and electronic based regulatory documents.
- Peer reviewing of documents like Drug Product, Drug Substance, Investigational Medicinal Product Dossier (IMPD).
- Perform quality checks on submissions for adherence to publishing requirements - communicating with authors/editors/reviewers for any missing material where necessary by email/chat.
- Document-level publishing to make documents submission ready as per the submission standards by creating internal and external links using the pdf tools in the published output. (e.g., bookmarking, linking, PDF version, Optimization etc.)
- Provide quality and timely deliverables to meet the client’s expectations.
- Mentors and supervising the new joiners.
Education
B. Pharmacy -
Swami Ramananda Tirtha Institute of Pharmaceutical Sciences
NalgondaIntermediate - undefined
Vasavi junior College
Miryalaguda, TelanganaSSC - undefined
Shivani school of foundation
Miryalaguda, TelanganaSkills
Editing and proofreading
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Declaration
I hereby declare that the information given above is true to the best to my knowledge.
Accomplishments
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Supervised team of [Number] staff members.
- Achieved [Result] through effectively helping with [Task].
Timeline
Submission Documentation Specialist
Bristol Myers Squibb
09.2023 - Current
Associate Regulatory Analyst
MAKRO CARE CLINICAL RESEARCH, Hyderabad
07.2022 - 08.2023
Associate Regulatory Publishing
DXC TECHNOLOGY, Hyderabad
03.2020 - 06.2022
Intermediate - undefined
Vasavi junior College
SSC - undefined
Shivani school of foundation
B. Pharmacy -
Swami Ramananda Tirtha Institute of Pharmaceutical Sciences