On building clinical and regulatory teams in India
India’s clinical ambition has outrun its regulatory bench.
The money is arriving and the trial sites are being built. The scarce input is the group of people who can run clinical and regulatory operations to the standards your filings depend on, and there are not many of them.
The ambition is real and well funded
India supplies around 20% of the world’s generic medicines, across roughly 60,000 brands in 60 therapeutic categories, with pharmaceutical exports of $30.47 billion in 2024-25, up 9.4%.
The direction of travel is away from volume manufacturing and toward research. In March 2026 the government announced Biopharma SHAKTI, a ₹10,000 crore programme to establish more than 1,000 accredited clinical trial sites.
For a foreign sponsor, CRO or device company, that’s an argument for building real clinical and regulatory capability here rather than treating India as a place to run data entry.
The constraint isn’t sites or patients
It’s the regulatory layer, and this is not a niche complaint. One assessment of the sector argues plainly that the national regulator has not built capacity at the pace India’s pharmaceutical ambitions have expanded.
When a regulator is stretched, the burden shifts to industry. Submissions need to be better prepared, queries need answering faster, and inspection readiness stops being an annual exercise. All of that rests on senior regulatory affairs and quality people, and the number of them who have carried a filing through to approval with a major agency from an India base is small.
The same pattern shows up on the clinical side. There are a great many capable clinical research associates and project managers. There are far fewer people who have owned a global study, managed the relationship with an ethics committee and a foreign regulator simultaneously, and held the line on data integrity under commercial pressure.
Why the usual search approach fails here
This market behaves differently from technology hiring, and briefs written by analogy to it tend to miss.
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The population is countable
- For a genuinely senior regulatory affairs or clinical operations role with a specific therapeutic area and a specific agency, the realistic field is often a couple of dozen people nationally. That changes the work from filtering applicants to knowing who they are and why any of them would move.
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The credentials are checkable, and they matter
- Unlike most commercial roles, the claims here are verifiable and the consequences of getting them wrong are regulatory rather than just commercial. Referencing has to be specific about what a person actually owned rather than what they were adjacent to.
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Reputation travels in a small world
- Therapeutic area communities here are tight. How candidates are treated during an approach gets discussed, and a clumsy process can close a market you will need again. This is true everywhere and much more true here.
What the good version looks like
The companies that build well here tend to do two things. They hire the quality and regulatory leadership earlier than the plan says they need to, because those people set the standard everyone hired afterwards works to. And they give that person real authority to stop things, which is the only way the role means anything.
That second point runs into the same structural issue as everywhere else in this sector. Indians hold roughly 10 to 13% of leadership positions in global capability centres, and a regulatory leader who cannot halt a submission is not a regulatory leader. Senior candidates know the difference and will ask.
The market is also about to get more competitive, not less. A thousand new trial sites need staffing, and the investment behind them is committed. Anyone planning to hire this capability in eighteen months is planning to do it in a tighter market than today’s.
The judgment
India’s clinical and regulatory ambition is funded and moving. The bench of people who can carry senior responsibility for it is small, slow to grow, and already being competed for.
Which makes this one of the few areas where hiring ahead of the plan is straightforwardly the right call, rather than the thing people say when they want to hire early.
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