Rabiea - Managing Director & Principal Regulatory Affairs Consultant

Rabiea

MPharm, UCL

Rabiea

Managing Director & Principal Regulatory Affairs Consultant

Regulatory Affairs Consultant with 10+ years of specialized regulatory affairs experience, combining unique perspectives from regulatory agency assessment, global pharmaceutical industry roles, and academic teaching excellence.

Honorary Professor

University College London (UCL)

Former MHRA

CMC Agency Reviewer

10+ Years

Industry Experience

UK Pharmacist

MPharm, UCL

Professional Background

A distinguished career spanning regulatory agency assessment, global pharmaceutical companies, and academic excellence.

Current

Managing Director

Advance Regulatory Consulting

Principal regulatory affairs contractor providing strategic CMC and regulatory support to biotech and pharmaceutical clients globally.

Current

Honorary Associate Professor

University College London (UCL)

Delivers guest lectures and workshops on regulatory affairs to MSc Drug Discovery students, curriculum development and mentoring.

Previous

CMC Assessor

UK Medicines and Healthcare products Regulatory Agency (MHRA)

Evaluated CMC sections of clinical trial and marketing authorization dossiers, reviewed impurity strategies and stability data.

10+ years combined

Senior Regulatory Affairs Positions

GSK, MSD, Bayer, Biogen

Technical writing, regulatory submissions, CMC submissions, site registration, and deficiency letter responses.

Areas of Expertise

Comprehensive regulatory expertise spanning strategy, technical writing, product categories, and education.

CMC (Chemistry, Manufacturing, and Controls)

Module 3 authoring
CMC dossier compilation
Manufacturing documentation
Quality systems compliance

Regulatory Strategy

Full product lifecycle support
Risk assessments and gap analyses
Regulatory intelligence
Agency liaison

Product Categories

Small molecules
Biologicals & biosimilars
ATMPs (gene & cell therapy)
Vaccines & medical devices

Technical Specializations

CMC dossier compilation
Module 3 authoring
Variation classification
Scientific advice preparation

Training & Education

Regulatory affairs courses
Career mentoring
Industry workshops
Academic lectures

Key Achievements

Proven track record of delivering exceptional results for clients across the pharmaceutical industry.

Delivered multimillion-dollar regulatory approvals across EU, UK, US, and international markets

Achieved substantial cost savings for pharmaceutical organizations through strategic regulatory planning

Successfully handled complex deficiency letters enabling numerous product approvals

Developed comprehensive training programs helping 500+ professionals enter regulatory affairs

Professional Services

Comprehensive regulatory consulting and educational services designed to accelerate your success.

Consulting Services

  • • Regulatory strategy development
  • • Module 1-3 authoring in CTD format
  • • Agency liaison and meetings
  • • Risk assessment and mitigation

Training Programs

  • • Entry to Regulatory courses
  • • Career mentoring programs
  • • Industry workshops
  • • Academic guest lectures

Thought Leadership

  • • LinkedIn publications (4,500+ followers)
  • • Regulatory strategy insights
  • • Industry best practices
  • • Career development guidance

Ready to Work with Rabiea?

Leverage Rabiea's unique combination of regulatory agency experience, industry expertise, and academic excellence for your next project.