Seun Sogbesan

Seun Sogbesan

Regulatory Affairs Former UK MHRA Assessor and TGA Evaluator

Regulatory science from both sides of the table.

I’ve worked on both sides of regulation, assessing medicines for the UK’s MHRA and the TGA, then spending 9 years at Pfizer getting product changes approved. Now I’m bringing that product-quality science (ingredients, suppliers, shelf life, packaging) to food, where I can keep contributing to people’s health.

  • Australian citizen
  • Based in Sydney
  • Open to food and nutrition regulatory roles
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A table seen from above, with a nutrition label under a magnifying glass on one side, a bowl of salad, an orange and wheat in the middle, and a yoghurt pot, a carton and a spoon on the other.

Both sides of the table

I know what a regulator will ask, so I plan for it before anything is submitted.

The regulator’s side

  1. 2017

    Therapeutic Goods Administration (TGA)

    Pharmaceutical Chemistry Evaluator

    Recruited to bring the MHRA’s assessment practice to the TGA as the 2 regulators built closer ties after Brexit. Assessed ingredient, impurity, manufacturing and shelf-life data, and gave companies practical, timely decisions.

  2. 2014 to 2016

    MHRA, the UK’s medicines regulator

    Accredited Pharmaceutical Assessor

    Assessed 15 new medicine applications and more than 100 changes to approved medicines, all within the legal deadlines. Accredited in 18 months, against a 2-year standard.

Industry’s side

  1. 2017 to 2026

    Pfizer Australia

    Regional Regulatory Hub Strategist (ANZ), and before that Senior Regulatory Affairs Associate

    The recognised technical expert for quality-related changes to about 70 products in Australia and New Zealand, explaining local requirements to teams in the US, the UK, India and China.

  2. 2008 to 2014

    AstraZeneca UK

    Formulation science, then regulatory submissions

    Co-led moving a late-stage tablet’s manufacture to a large-scale site in Puerto Rico, then delivered post-approval submissions for 2 products with sales of over $1 billion a year.

Industry from 2008, then the regulator from 2014, then industry again from 2017.
  1. AstraZeneca 2008 to 2014
  2. MHRA, then TGA 2014 to 2017
  3. Pfizer 2017 to 2026

Education and training. Master of Pharmacy (Honours), University of Nottingham Business Leadership and Team Leadership, McKinsey Academy

Volume with judgement

High volume, and knowing what to escalate.

  • about5

    proposed changes reviewed a day, against Australian and New Zealand requirements

  • about70

    products in Australia and New Zealand, as the recognised technical expert on quality-related changes

  • 6 of 6

    applications approved within 6 months when Pfizer left its West Ryde site, so supply carried on from the new sites

Stability testing, once a year

I led the strategy for cutting routine stability testing to once a year on 10 to 15 established products. When the TGA asked for more data on the first 2, I weighed challenging it against supplying data we already held, chose to supply it, and agreed one approach for the rest. The successful strategy led to the remaining products being approved without further questions.

A new expectation at Medsafe

I spotted that Medsafe, New Zealand’s medicines regulator, now expected stability data before approving a change of stability-testing site. I escalated it rather than rely on past assumptions and, once Medsafe confirmed it, led colleagues to an agreed position for past and future changes.

Same discipline, new code

Product-quality science carries straight into food.

My daily work was the science behind a product’s quality, from what goes into it and who makes it to how long it lasts and what the label says. Food regulation asks the same questions under a different code, with the same link to people’s health.

  • Ingredients

    Formulation, raw-material and impurity changes, deciding the data and pathway each one needed.

  • Suppliers and sites

    Supplier and manufacturing-site changes, including the move of 6 key products to overseas sites, all approved within 6 months.

  • Shelf life

    Stability data and shelf-life decisions, such as whether data generated for Europe’s cooler climate could support a longer shelf life in Australia.

  • Labels

    Manufacturing and labelling changes, each assessed for its regulatory impact.

That’s why I’m moving into food, to keep contributing to health through food while learning the Food Standards Code from experienced people.

Lifting people up

Coaching, training, and turning up on race day.

  • Started a fortnightly peer-support group for new assessors at the MHRA, and gave careers talks to about 80 delegates at the Academy of Pharmaceutical Sciences’ Industrial Insights conferences in 2015 and 2016.
  • Coached less experienced colleagues, and trained the new team in the Philippines that took over part of Pfizer’s regional hub work, improving each session from their feedback.
  • Ran 6 wellbeing sessions for colleagues in 8 countries after a staff survey flagged work-life balance.
  • Co-led Pfizer ANZ’s Gender Equity Colleague Resource Group, 2025 to 2026.
  • On site in Puerto Rico for 2 weeks, trained the mostly Spanish-speaking local team while running full-scale batches to a tight deadline.
  • Volunteer marshal at parkrun and the Sydney Marathon.

Get in touch

Let’s talk about food and nutrition regulation.

I’m an Australian citizen based in Sydney, open to food and nutrition regulatory roles and available now. LinkedIn is the best way to reach me.

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