eCTD Submissions & Regulatory Publishing Expert

MOHAMMAD SAIF KHAN

Thane, Maharashtra +91-903******* ********@*****.***

PROFESSIONAL SUMMARY

eCTD Publishing Specialist with 9+ years of experience managing 750+ annual US FDA submissions across IND, NDA, BLA applications at Tata Consultancy Services. Expert in VEEVA Vault RIM, eCTD lifecycle sequencing, and FDA ESG transmission. Consistent zero-rejection record across high-volume submission programs with full 21 CFR Part 11 and ICH M8 compliance.

CAREER OBJECTIVE

Targeting a Senior eCTD Publishing / Regulatory Submissions role in an in-house pharma or biotech environment, leveraging 9+ years of hands-on US FDA submission publishing experience and deep VEEVA Vault RIM expertise.

CORE COMPETENCIES

Regulatory Domain

US FDA Submissions – IND, NDA, BLA • eCTD Publishing & Lifecycle Management eCTD Lifecycle Sequencing (New / Replace / Append / Delete) • ISO IDMP Standards & CMC Regulatory Activities

21 CFR Part 11 Compliance • ICH Guidelines • Post-Approval Submissions FDA ESG Submission & Rejection Resolution • SOP Development & Process Optimization Tools & Systems

VEEVA Vault RIM & PromoMats • ISI Toolbox & InSight Publisher • eValidator Adobe Acrobat Professional • FDA ESG (Electronic Submissions Gateway) Submission Types

IND / NDA / BLA • DSUR, IB, PADER/PBRER, SAP

OPDP / Form 2253 • Investigator Packages (Forms 1571/1572) PROFESSIONAL EXPERIENCE

Regulatory Affairs Associate Tata Consultancy Services (TCS), Mumbai Aug 2017 – Present US FDA Submission & eCTD Management

• Publish and submit 750+ eCTD sequences annually via VEEVA Vault RIM across IND, NDA, BLA applications, maintaining a consistent zero-rejection record at FDA ESG.

• Build and manage eCTD lifecycle sequences — including new, replace, append, and delete operations — ensuring correct backbone structure, metadata tagging, and ICH M8 compliance across all submission types.

• Execute end-to-end technical publishing for DSUR, IB, PADER/PBRER, SAP, OPDP, and Investigator Packages, covering PDF/A compliance, bookmarking, hyperlinking, and document-level QC prior to submission.

• Manage OPDP/DDMAC promotional material submissions (Form 2253) and Investigator Packages (Forms 1571/1572) through VEEVA PromoMats and Vault, ensuring regulatory format compliance and on-time FDA ESG transmission.

• Perform pre-submission validation and resolve technical errors to ensure clean, audit-ready packages meeting 21 CFR Part 11 and FDA ESG technical specifications.

• Serve as SME for eCTD formatting and submission readiness, advising cross-functional teams on metadata standards, sequence logic, and non-eCTD formatting requirements. Regulatory Document Publishing

• Lead end-to-end publishing and QA review for Drug Safety Reports, Clinical Study Reports, Non-Clinical Reports, SAPs, Data Memos, NSRs, and Literature References in compliance with global regulatory standards.

• Apply document formatting and compliance checks for multiple global regulatory authorities, streamlining document management workflows and reducing review cycle times.

• Advise US clients on regulatory documentation strategy and process improvement, serving as key point of contact for complex submission queries and ongoing process optimization. Regulatory Affairs Trainee iMedGlobal Solutions, Bengaluru Jun 2015 – Jul 2017

• Carried out ISO IDMP CMC regulatory activities including dossier gap analysis, core dossier compilation, Product Substance element extraction, and Health Authority query responses.

• Monitored real-time progress of ISO IDMP standards finalization (2015–2016), aligning product and substance dossiers with evolving regulatory requirements to ensure zero compliance gaps.

• Developed and standardized ISO IDMP-compliant working processes for cross-functional teams; trained offshore colleagues on CMC, eCTD, and regulatory submission requirements.

• Managed centralization and translation of local dossiers into ISO-compliant format, supporting global regulatory submissions across multiple markets with multilingual data integrity. EDUCATION

Master of Pharmacy (M.Pharm) K.L.E. Society's College of Pharmacy, Bengaluru 2013 Bachelor of Pharmacy (B.Pharm) K.L.E. Society's College of Pharmacy, Bengaluru 2009

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