Regulatory Submission Management
End-to-end management of promotional and medical material submissions — from initiation through final approval, routing, publishing, and deployment across global brands.
Available for work
Hi, I'm Omer Wasiq
Senior Regulatory Operations Specialist with 8+ years of experience in Veeva Vault PromoMats, eCTD publishing, and promotional compliance for global pharma brands.
8+
Years experience
5+
Pharma clients
2
Top agencies
Open to projects
What I do
Services
Veeva Vault PromoMats & RIM
Expert-level document preparation, metadata tagging, QC, routing, and lifecycle management within Veeva Vault PromoMats and Vault RIM. Including DAM administration.
Promotional Compliance Review
Rigorous review of medical and promotional materials against FDA, EMA, ABPI, and EFPIA requirements. Ensuring scientific accuracy, audit readiness, and full SOP compliance.
Portfolio
Selected work
Regulatory Ops
Veeva PromoMats
JNJ · Novartis · GSK · AZ
Area 23 (IPG Health) — Senior Reg Ops
Providing regulatory operations leadership for multiple global pharmaceutical clients at one of New York's premier healthcare agencies. Managing the complete lifecycle of promotional and medical material submissions, Veeva Vault systems administration, DAM management, and cross-functional stakeholder coordination across Johnson & Johnson, Novartis, GSK, and AstraZeneca brands.
Key brands: Darzalex, Tremfya, ICOTYDE (JNJ) · Cosentyx, Kesimpta, Leqvio (Novartis) · Zejula (GSK) · Fasenra (AstraZeneca).
Medical Editor
London
McCann Health London — Medical Editor
End-to-end regulatory operations and promotional review support across JNJ and Novartis brands. Quality-checked and routed materials through Veeva PromoMats, maintained audit trails and submission libraries.
View case study →
Research
Pharma Sciences
Master's Thesis — Drug Formulation Research
Postgraduate research spanning oral extended-release formulation, osmotic drug delivery systems (Valsartan), and clinical safety/efficacy evaluation. Available to view and download below.
View research →Partners
Selected Clients & Brands
A summary of global pharmaceutical organizations and brands I have proudly supported.
Johnson & Johnson
Darzalex
Tremfya
ICOTYDE
Novartis
Cosentyx
Kesimpta
Leqvio
Pelacarsen
GSK
Zejula
AstraZeneca
Fasenra
Bayer
Kerendia (Finerenone)
Sanofi
Flublok
Takeda
Obizur
Amgen
Uplizna
Acadia
Daybue
Ionis
Dawnzera
Executive Profile
A bit about
who I am
I'm Omer Wasiq, a Regulatory Operations professional with 8+ years of experience supporting global pharmaceutical and healthcare organizations. Specialized in Veeva Vault PromoMats, Vault RIM, promotional review workflows, DAM management, metadata governance, submission lifecycle management, and cross-functional stakeholder collaboration.
Delivered regulatory operations support for leading pharmaceutical companies including Johnson & Johnson, Novartis, AstraZeneca, GSK, Bayer, Sanofi, Takeda, Amgen, Acadia, and Ionis.
Key Achievements
- Supported multiple global pharmaceutical portfolios across North America, Europe, and international markets.
- Managed end-to-end promotional review and submission workflows within Veeva Vault environments.
- Delivered DAM upload and asset governance support for Johnson & Johnson programs.
- Maintained audit-ready submission repositories, metadata accuracy, and document traceability.
- Collaborated with Medical, Legal, Regulatory Affairs, and Commercial teams to accelerate compliant approvals.
- Contributed to process improvements that enhanced submission efficiency and operational consistency.
Skills Matrix (Advanced Proficiency)
Veeva Vault PromoMats
Veeva Vault RIM
Regulatory Operations
Promotional Review
Metadata Management
DAM Uploads & Governance
Regulatory Compliance
Submission Management
Audit Readiness
Stakeholder Management
Executive Endorsement
Global Talent Visa Readiness Highlights
A proven track record of exceptional contribution to internationally recognized pharmaceutical organizations and deep specialist expertise in highly regulated life sciences environments.
- Demonstrated contribution to internationally recognised pharmaceutical organizations.
- Specialist expertise in highly regulated life sciences environments.
- Evidence of impact across multiple global healthcare brands.
- Cross-border collaboration with UK and US healthcare communications agencies.
- Proven track record in regulatory technology platforms and compliance operations.
Journey
Experience & Education
As a freelancer I have executed various projects for Clients like JNJ, AstraZeneca, GSK, Novartis, BMS and much more via Healthcare agencies in the UK and USA.
01
Freelance Experience
Area 23 (IPG Health)
Senior Reg Ops Specialist • 2025 – Present
Providing regulatory operations leadership for multiple global pharmaceutical clients. Managing the complete lifecycle of promotional submissions and Veeva Vault administration.
McCann Health London
Medical Editor (Freelance) • 2025
End-to-end regulatory operations and promotional review support. Maintained metadata accuracy and submission histories for JNJ and Novartis brands.
02
Educational Journey
Master's in Pharmaceutical Sciences
Drug Formulation Research
Postgraduate research spanning oral extended-release formulation and osmotic drug delivery systems. Developed a deep understanding of clinical safety and efficacy evaluation.
Scientific Foundations
Biomedical & Healthcare Research
Foundational studies in pharmacology, regulatory frameworks, and healthcare systems, preparing the groundwork for advanced regulatory operations.
Research
Publications & Papers
A selection of my academic research, theses, and pharmaceutical publications available for reading and download.
Formulation and In-vitro Evaluation of Oral Extended Release
Comprehensive research detailing the formulation process and in-vitro testing methodologies for extended-release oral delivery systems.
Read PaperOsmotic Drug Delivery System of Valsartan
A detailed study exploring the development, optimization, and evaluation of an osmotic drug delivery system for Valsartan.
Read PaperTo Evaluate Safety and Efficacy of Tedizolid
An analytical review and evaluation covering the safety profile and clinical efficacy of Tedizolid in pharmacological applications.
Read PaperResearch Publication (Ref: 726803)
Additional research and analytical studies within the field of pharmaceutical sciences and clinical evaluation.
Read PaperIJMS Publication Citation
A published citation featured in the International Journal of Molecular Sciences (IJMS), highlighting advanced pharmaceutical research.
Read PaperMaster of Pharmacy Project
Detailed thesis project and academic research completed during the Master of Pharmacy program.
Read ProjectSocial proof
What clients say
"Omer's attention to detail and deep understanding of Veeva PromoMats is outstanding. He managed our entire JNJ submission library with zero errors over an 18-month engagement. Truly an expert in the field."
"Omer seamlessly integrated into our team from day one. His regulatory expertise, submission accuracy, and ability to manage multiple brand timelines simultaneously is exceptional. He's our go-to specialist."
"Omer brings a rare combination of scientific rigour and operational precision. His background in pharmaceutical sciences means he actually understands the content he's reviewing — a huge advantage in pharma regulatory ops."
Get in touch
Let's work
together
I'm available for freelance regulatory operations engagements — short or long-term contracts with UK and USA healthcare agencies. Veeva Vault expertise, promotional compliance, submission management. Let's talk.