Omer Wasiq — Curriculum Vitae

01 · Nine years · Regulatory operations

Profile

Pharmaceutical regulatory operations professional with nine years across regulatory submissions, eCTD publishing, promotional-material (MLR) review workflows, quality control and metadata governance. Currently supporting end-to-end promotional submission workflows for global biologic brands.

Developer of ClaimFlow, an independently conceived research concept for AI-assisted claim-to-evidence traceability in regulated pharmaceutical workflows, now being developed into a formal research programme with UK host institutions.

02 · 2015 – present

Professional experience

Senior Regulatory Operations Specialist (freelance)

Aug 2025 – present

Area 23, IPG Health · remote

End-to-end submission lifecycle support across global brands, including the promotional workflow of a global immunology biologic: document preparation, QC routing, claims tagging and linking, change annotations, and progression through approval to distribution in Veeva PromoMats and Vault RIM.
Maintain master submission libraries for consistency, traceability and version control; apply FDA, EMA, ABPI and EFPIA promotional-compliance frameworks in content review.
Completed client-mandated systems and compliance training (January 2026): medical review platform, copy approval process, healthcare compliance, and embargoed-data and asset-expiry management.

Medical Editor (freelance, concurrent)

Jun 2025 – Dec 2025

McCann Health · London

Regulatory operations support across pharmaceutical brands: eCTD submission packages, promotional review packages and approval cycles; quality gatekeeping of medical and promotional materials against client SOPs and agency standards.

Senior Associate QC Specialist

Nov 2023 – Aug 2024

Novartis Healthcare · Hyderabad

Independent source-data verification of clinical and preclinical summary documents, with 100% factual and numeric review against post-text sources; citation appropriateness checks; QC of CSRs, CERs, tabular listings and clinical summaries prior to promotion in the document-management system.

Senior Regulatory Submission Specialist

Sep 2021 – Apr 2023

Fishawack, Avalere Health · London

Managed MLR electronic review processes for client committees across more than 100 pharmaceutical messaging approvals; created and maintained reference libraries and claims matrices; delivered error-free linking, tagging and annotation for prompt approval decisions.

Regulatory Publishing Associate Professional

Sep 2017 – Apr 2021

DXC Technology · Hyderabad

Document-level publishing and QC within the eCTD lifecycle for global pharmaceutical portfolios, including third-party source documents from contract research organisations; ISI Publisher, ISIToolbox and PRISM automation processes.

QA and QC Analyst (trainee)

2016 – 2017

Active Pharma Labs · Hyderabad

Hands-on analytical quality control training: HPLC, GC, UV spectrophotometry and wet analysis.

Pharmacist

2015 – 2016

CARE Hospitals · Hyderabad

Prescription review, drug-interaction checking, controlled-drug records (Schedule H/X), procurement and inventory management; training of pharmacy support staff.

03 · 2026 →

Research and innovation

Concept · Sole author · 2026

ClaimFlow

AI-assisted claim-to-evidence traceability for regulated pharmaceutical content workflows, with a proposed quantitative traceability measure, RCETS. Being developed into a registered research programme with UK host institutions.

In preparation

Registered original research

Publicly registered studies (OSF / PROSPERO) in regulatory science and pharmaceutical sciences, targeting Scopus-indexed journals. Human-in-the-loop governance, open benchmark from public regulatory sources.

Programme elements

01: Workflow and failure-mode mapping of claim–evidence linking
02: Semantic matching of claims, evidence and prior annotations, evaluated against string-based baselines
03: RCETS validation on an open benchmark built from public regulatory sources
04: Human-in-the-loop governance: thresholds, escalation, audit-ready records
05: Extension: Regulatory Publishing Risk Score (RPRS) for submission rework

04

Areas of expertise

Regulatory: Regulatory submissions and eCTD publishingClaims tagging, linking and change annotation · MLR review coordination · promotional compliance across FDA, EMA, ABPI and EFPIA frameworks.
Quality: Quality assurance and controlSource-data verification · metadata governance and audit readiness · reference libraries and claims matrices · process improvement.
Systems: Veeva Vault PromoMats and Vault RIMeCTDXPress · ISI Publisher and ISIToolbox · Lorenz DocuBridge.

05

Education

Postgraduate: Master of Pharmacy, PharmaceuticsJawaharlal Nehru Technological University, Hyderabad · First Class · awarded 2016.
Ecctis: UK ENIC statement of comparabilityComparable to a UK Master's degree · statement issued 14 April 2022.
Undergraduate: Bachelor of PharmacyJawaharlal Nehru Technological University, Hyderabad · 2013.

06

Memberships and continuing development

Membership: Registered Member, TOPRA (MTOPRA)The Organisation for Professionals in Regulatory Affairs.
Membership: Member, Royal College of PharmacyPharmaceutical Scientist category.
CPD: TOPRA CPD programme2022 – 2023.
Training: Client systems and compliance trainingMedical review platform, copy approval, healthcare compliance · 2026.
Certification: Enterprise document platform certification2025.
Certificates: Alison professional training certificatesFull CPD record on request.

07

Languages and references

English, C2. References available on request.

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