Setting up a regulatory function in Singapore: is hiring always the most practical option?

Many companies expanding into a new territory such as Singapore or ASEAN initially consider setting up a local regulatory function or hiring a full-time regulatory staff.

However, in practice, this approach may not always be efficient — particularly during early market entry, when product pipelines are still being established or when regulatory workload is not yet consistent. Companies may face challenges such as delays in hiring the right candidate, limited local expertise for specific product categories, or gaps in support during peak submission periods or staff transitions.

In such situations, alternative operating models may be considered to ensure continuity and flexibility in regulatory support.

A regulatory subscription plan is a model developed by TRC to support companies requiring local regulatory expertise without the need to establish a full in-house function.

This may be relevant in scenarios where:

there is no local office established in the territory
support is required primarily for post-licensing activities
interim or supplementary support is needed while hiring is ongoing
companies are exploring alternative ways of structuring their regulatory operations
an independent party is required to manage or balance regulatory responsibilities between parent and local entities

The plan allows companies to leverage local regulatory expertise to support routine and project-based activities typically handled by a regulatory specialist or head of regulatory function.

This includes day-to-day operational support on an ad hoc basis, assistance during peak workload periods, short-term coverage (e.g. maternity or transition periods), as well as support for specific regulatory initiatives and ASEAN-level coordination.

The comparison below reflects common operational considerations observed when companies establish or scale their regulatory function in Singapore. The suitability of each model depends on the company’s stage of development, regulatory workload, and internal capabilities.

Comparison parameters	Regulatory Subscription Plan	Traditional Model
Working Principle	Flexible model providing access to regulatory expertise with established local experience.	Hiring a staff to manage the regulatory work based on requirements.
Cost	Fixed cost for experienced personnel. May be more cost-effective compared to hiring, particularly for post-licensing and ad-hoc new product activities.	Can vary depending on the level of expertise from personnel engaged. May result in higher long-term cost, particularly if downsizing or restructuring is required.
Manpower	Experienced resources readily available. Dedicated regulatory support provided (no additional project management layer).	Requires time for hiring, onboarding, and training before full functionality is achieved. Dedicated employee .
Resource allocation and commitment Time to readiness	No long-term commitment required. Able to support a range of functions, including pre-launch activities such as regulatory intelligence, project management and post approval activities such as variations. Immediate access to experienced regulatory support.	Employment commitment required, even on a contractual basis, with potential legal and administrative implications. Scope is typically fixed based on job function, with limited flexibility beyond defined responsibilities. Time required for recruitment, onboarding, and familiarisation with internal processes.
Determining factor in choosing the right model	No local office and require experienced support to initiate regulatory activities efficiently. Limited budget with short timelines. Need for flexible, non-committed support during transition periods or internal restructuring. Exploring alternative operating models for regulatory function.	Established presence in the territory with stable operations. Sufficient budget to build and maintain an internal team. Requirement for a dedicated, long-term regulatory function A conventional model that has been widely adopted, particularly in organisations with stable operations and low staff turnover.

In some cases, companies may only recognise these challenges after delays in regulatory timelines or increased internal coordination burden.

If your organisation is currently facing challenges in hiring or maintaining consistent regulatory support in Singapore or ASEAN, a subscription-based model may be considered as an alternative approach.

You may reach out to TRC for a discussion to assess whether this approach aligns with your current regulatory needs.

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