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Senior Regulatory Experts - Complementary and Natural Health Products Marketing Authorization Framework
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MULTIPLE ROLES | SENIOR REGULATORY EXPERTS
Complementary and Natural Health Products Marketing Authorization Framework
We are sourcing a panel of up to 10 senior regulatory experts to support a proposal for a GCC federal regulator designing a modern marketing authorization framework for complementary and natural health products.
KEY DETAILS
- Profiles due: Tuesday 21 July 2026, 6:00pm UAE
- Expected start: 15 August 2026
- Duration: 4 to 5 months
- Utilization: Variable, up to 30 days
- Daily rate: USD 1,200 to 2,500
- Location: GCC
- Work arrangement: Remote, with limited onsite if required
ABOUT THE ENGAGEMENT
A GCC federal regulator responsible for medical products is designing and operationalizing a comprehensive marketing authorization framework for complementary and natural health products. The work spans regulatory governance, marketing authorization guidelines, decision-making models, and Standard Operating Procedures, establishing a modern, internationally aligned framework consistent with global best practice.
Objectives:
- Design a future-state framework that is flexible and agile
- Develop approximately 20 Marketing Authorization Guidelines
- Develop approximately 24 Standard Operating Procedures (SOPs)
- Design governance and regulatory decision-making models
- Improve regulatory efficiency, consistency, and transparency
- Introduce risk-based and reliance-based regulatory pathways
- Support digital regulatory transformation
- Strengthen lifecycle management and post-market oversight
- Align the framework with international regulatory best practices
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Products in focus: herbal medicines, natural source medicines, homeopathic products, medicated cosmetics, antiseptics, and related healthcare products.
Out of scope: pharmaceuticals, biologics, medical devices, in vitro diagnostics (IVDs), veterinary products, and advanced therapy medicinal products (ATMPs).
MUST-HAVE EXPERIENCE
- 10+ years regulating complementary and natural health products, with a national regulatory authority
- Direct experience with one or more of the in-focus product categories above
- Developing marketing authorization guidelines, SOPs, governance, and regulatory decision-making models
WHO WE ARE LOOKING FOR
Senior experts (Executive, Director, or Senior Manager level) with direct experience within national regulatory authorities or advising governments on regulatory framework development. Preference for former regulators, senior reviewers, policy designers and leaders, guideline authors, and committee members. Undergraduate, postgraduate, and doctoral qualifications all considered.
EXPERT ROLES REQUIRED (x10)
- Regulatory Governance - Regulatory governance, operating model design, regulatory policy, committee governance, and institutional design. (WHO, EMA, MHRA)
- Marketing Authorization - Marketing authorization, dossier assessment, product registration, lifecycle management, renewals, and variations. (FDA, EMA)
- Herbal & Natural Products - Herbal medicines, natural source medicines, homeopathy, complementary medicines, medicated cosmetics, and antiseptics. (Health Canada NNHPD, EMA HMPC, BfArM)
- Regulatory Policy & Guidelines - Development of regulatory guidelines, policies, technical guidance documents, and evidence requirements. (EMA, FDA, WHO)
- SOP & Regulatory Operations - SOP development, regulatory workflows, scientific assessment procedures, committee processes, and submission validation. (EMA, MHRA, SFDA)
- Scientific Assessment - Quality, safety and efficacy evaluation, toxicology, clinical evidence, and stability assessment. (FDA, EMA, Health Canada)
- Risk-Based & Reliance Pathways - Reliance models, recognition pathways, fast-track approvals, conditional approvals, and regulatory convergence. (WHO, EMA, TGA)
- Digital Regulatory Transformation - Digital submissions, Regulatory Information Management (RIM), structured regulatory data, and workflow automation. (EMA, FDA, Health Canada)
- Quality & Manufacturing - GMP, quality management systems, raw material assessment, and quality standards. (FDA, EMA, TGA)
- Project Quality Reviewer / Technical Editor - Regulatory document review, consistency, document quality assurance, and technical writing.
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