Area 23 (IPG Health) — Senior Regulatory Operations Specialist

The engagement

Area 23, part of IPG Health — one of the world's leading healthcare advertising groups — engaged me as a Senior Regulatory Operations Specialist. Working across multiple global pharmaceutical accounts simultaneously, I serve as the regulatory operations backbone for their client teams, ensuring all promotional and medical materials meet FDA, EMA, ABPI, and EFPIA requirements before deployment.

The scope spans the complete submission lifecycle: from initial document setup, metadata tagging, and routing configuration in Veeva Vault PromoMats, through to final approval, archival, and DAM deployment. I manage multiple parallel brand campaigns with different approval timelines, stakeholder teams, and regulatory jurisdiction requirements.

"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."

Clients & brands managed

Johnson & Johnson

Managing regulatory operations for three major JNJ brands: Darzalex (daratumumab, multiple myeloma), Tremfya (guselkumab, plaque psoriasis), and ICOTYDE. Each brand carries distinct submission requirements, medical/legal/regulatory (MLR) committee structures, and promotional material categories spanning digital, print, congress materials, and sales tools.

Novartis

Providing regulatory operations coverage for three Novartis brands: Cosentyx (secukinumab, psoriasis/PsA/AS), Kesimpta (ofatumumab, relapsing MS), and Leqvio (inclisiran, LDL-C reduction). Each requires careful management of indication-specific claims, black box warning placements, and multi-market adaptation workflows.

GSK & AstraZeneca

Supporting Zejula (niraparib, ovarian cancer; GSK) and Fasenra (benralizumab, severe eosinophilic asthma; AstraZeneca) promotional operations, including HCP-facing materials, patient education content, and congress presentations.

Core responsibilities

Veeva Vault PromoMats administration

Managing the complete Veeva Vault PromoMats environment for multiple client accounts simultaneously. This includes document type configuration, custom metadata taxonomy design and maintenance, user role assignment, workflow routing logic, SOP compliance checks, and training new team members on system use. I maintain audit trails and submission libraries to ensure materials are always retrievable and compliant.

Submission lifecycle management

From submission initiation through final approval and archival, I manage every touchpoint of the material lifecycle. This includes: coordinating with scientific, legal, compliance, and marketing stakeholders; routing materials through multi-tier MLR review processes; tracking comments, revisions, and version control; and ensuring final approved materials are correctly distributed to DAM systems for deployment.

DAM administration

Administering Digital Asset Management systems to ensure approved promotional materials are correctly tagged, accessible, and version-controlled. This includes managing asset metadata, deprecation workflows for outdated materials, and access controls for different stakeholder groups across agency and client teams.

Regulatory compliance framework

All materials I manage are reviewed against applicable regulatory frameworks:

• FDA (USA): 21 CFR Part 202 promotional labelling requirements, risk communication standards, fair balance requirements
• EMA (EU): Directive 2001/83/EC advertising provisions, EFPIA Code on interactions with healthcare professionals
• ABPI (UK): Code of Practice for the Pharmaceutical Industry, including digital/social media guidelines
• EFPIA: Code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals

Master's research — downloadable thesis

My regulatory operations expertise is underpinned by a strong scientific foundation. I hold a Master's degree in Pharmaceutical Sciences, with a thesis covering:

• Oral extended-release drug formulation and matrix tablet design
• Osmotic oral drug delivery systems (OROS) applied to Valsartan
• In vitro release kinetics and bioequivalence assessment frameworks
• Clinical safety and efficacy evaluation methodology

This scientific grounding gives me a unique ability to engage with complex medical content, understand pharmacological claims at a deep level, and support medico-legal review teams with scientific accuracy checks.

Reflections

The most important lesson from 8+ years in pharmaceutical regulatory operations is that precision and process discipline are non-negotiable. A single metadata error or missed SOP step can delay a product launch, trigger a regulatory query, or expose an organisation to compliance risk. The best regulatory ops professionals are those who combine deep system knowledge with scientific curiosity and genuine stakeholder partnership.

Working across multiple global brands simultaneously demands a level of organisational rigour and context-switching ability that I've continually refined. Each brand has its own therapeutic area nuances, medical community expectations, and regulatory jurisdiction requirements — understanding these distinctions makes me a more effective partner to the scientific, marketing, and legal teams I support.

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Interested in a regulatory operations engagement? Get in touch — I'm available for freelance contracts with UK and USA pharma agencies.