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
Reg Ops
London
McCann Health London — Medical Editor & Reg Ops
Jun 2025 – Dec 2025
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
Professional Experience
Area 23 (IPG Health)
Senior Reg Ops Specialist • Aug 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 & Reg Ops (Freelance) • Jun 2025 – Dec 2025
End-to-end regulatory operations and promotional review support. Maintained metadata accuracy and submission histories for JNJ and Novartis brands.
Novartis Healthcare Private Limited | Hyderabad
Senior Associate QC Specialist • Nov 2023 – Aug 2024
Assessed validity of clinical/scientific content in preclinical and clinical documents. Provided independent source data verification of clinical study reports and identified content inaccuracies. Developed factual evidence to support discrepant findings.
Fishawack Communications Ltd | London
Senior Regulatory Submission Specialist • Sep 2021 – Apr 2023
Oversaw Medical-Legal Regulatory (MLR) review processes for clients, enabling successful planning and approval of over 100+ pharmaceutical messaging. Developed strong expertise in Veeva Vault PromoMats and managed electronic review processes.
DXC.Technology | Hyderabad
Regulatory Publishing Associate • Sep 2017 – Apr 2021
Executed QC tasks within electronic publishing system for accurate published output. Supported senior submissions teams in maintenance of eCTD lifecycle. Achieved excellence in leading Document Level Publishing for Bristol Myers Squibb.
Active Pharma Labs | Hyderabad
QA & QC Analyst • 2016 – 2017
Conducted quality assurance and quality control analysis, supporting internal processes and regulatory compliance within the pharmaceutical framework.
02
Educational Journey
Master of Pharmacy, Pharmaceutical Sciences
Jawaharlal Nehru Technological University • 2013 – 2015
Postgraduate research spanning oral extended-release formulation and osmotic drug delivery systems. Developed a deep understanding of clinical safety and efficacy evaluation.
Bachelor of Pharmacy
Biomedical & Healthcare Research
Foundational studies in pharmacology, regulatory frameworks, and healthcare systems, preparing the groundwork for advanced regulatory operations.
Professional Certifications & Training
TOPRA, Summit, Fuse, Alison & Active Pharma Lab
Continuous professional development through over 15 targeted certifications in Regulatory Affairs, Document Automation, and Medical Review processes to stay at the cutting edge of industry compliance.
Scholarly Peer Review & Editorial Activities
Academic & Pharmaceutical Journals
Active contributor to the scientific community through peer review of academic manuscripts and editorial responsibilities, ensuring the highest standards of scientific integrity and quality.
Academic Honors & Awards
DXC Quarterly Champ Awards & Recognitions
Recognized for outstanding contributions, academic excellence, and continuous dedication to the field of regulatory operations and pharmaceutical sciences.
Publications & Research
Various Publication Listings
Authored and contributed to multiple scientific publications spanning oral extended-release formulations, osmotic drug delivery systems, and clinical efficacy evaluations. View full publication list.
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 PaperPrescribing Trends in Respiratory Tract Infections
A study on prescribing trends in respiratory tract infections in a tertiary care hospital — published research in pharmaceutical clinical practice.
Read PaperLinkedIn Endorsements
What colleagues say
"It is my pleasure to strongly recommend Omer Wasiq for the role of Senior Regulatory Submission Specialist. During our two years working together, Omer became an advanced Veeva Vault PromoMats user. He is adept at reference linking and comment annotating in that platform. Omer displays strong organizational and communication skills, always making detailed notes for current and upcoming projects, and never hesitating to reach out for help. In addition to Omer’s technical capabilities, he is congenial and levelheaded, an absolute joy to work with!"
"Omer is the hardest working team member I have ever had the pleasure to manage. When I joined Fishawack Health, Omer had assumed regulatory submission ownership over the entire UK Marketing line of business. He consistently goes above and beyond to meet his teams deadlines while remaining gracious, kind, and humble. He is meticulous and detail-oriented and holds himself to a very high standard. Omer takes pride in his work and communicates effectively across departments. Omer has so much to offer and would be an asset to any organization!"
"Omer is always approachable and very professional in his work, demonstrating a clear understanding of the VEEVA platform and process. His work ethic is second to none, going above and beyond to deliver a project to high quality. With his knowledge and manner he is always a pleasure to work alongside."
"Omer has demonstrated exceptional proficiency in managing regulatory submissions, showcasing a very good understanding of Veeva management systems."
"Omer is a very dedicated and skilled Regulatory Operations Specialist. He will work as many hours as it takes to complete a task and never complains. His attention to detail is especially strong and works extremely well with others. He also adapts well to any situation and his knowledge of the Veeva platform is very strong. Omer is also a strong communicator and works extremely well with others on his regulatory team as well as with the teams he supports. I give Omer my highest recommendation. You won’t be disappointed."
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.