Full Time Head of Product Development and Regulatory Jobs, in CellResearch Consumer Health - Maukerja

About the job

Head of Product Development & Regulatory

· Singapore · Reports to Group COO

About us

CellResearch Corporation was founded in Singapore in 2002. In 2004 our scientistsisolated epithelial and mesenchymal stem cells from the umbilical cord lining membrane.Patents in key territories worldwide now protect that discovery, covering isolation,banking, cultivation and therapeutic use.

Today that platform runs in two directions. One is CALECIM, a consumer cosmeceuticalsbusiness selling skincare and haircare globally. The other is a therapeutics arm developingtreatments for conditions including diabetic foot ulcers. We hold SME designation fromthe European Medicines Agency and an Innovation Passport from UK regulators.

CALECIM sells direct to consumers in the US, UK, Canada, Australia and Europe. It alsosells through distributors, clinics and pharmacies across Europe and Asia. The business isgrowing, and the way we build products needs to grow with it.

The role

Our product work runs in two streams. New products go from brief to shelf throughformula, packaging, testing, regulatory clearance and production. Existing products gointo new markets, which means checking the formula and claims against local rules,adapting labels, and supplying the documents that distributors and regulators ask for.Today this work is split across a formulation consultant, outside regulatory agents, theoperations team and the COO. Nobody owns either stream from start to finish.

We're hiring one person to own it: product development and regulatory compliance in asingle role. Most delays and compliance problems start where the two meet, so we wantboth handled by the same person.

This is a commercial role first. Success means good products reaching more markets,sooner, with compliance built into the plan from day one rather than added as a gate atthe end.

You'll be the first hire into this function, and you will shape how it works.

How you'll work

Most of the job is internal. You'll plan each project, track it across teams, preparedocuments and keep every product's records current. You'll also work with outsidepartners. They include our formulation consultant, who develops formulas and packagingwith you, contract manufacturers in Korea and Singapore, packaging suppliers, testinglabs, Responsible Persons in the EU, UK and US, and our distributors and their localregistration agents. You'll have several projects running at once, some new launches andsome market registrations, each at a different stage.

You'll set the plan for each product and review what partners send back: formulas, testreports, label reviews and safety assessments. Then you decide what is ready to moveforward. You'll need to know the subject well enough to catch an error before it reaches afiling or goes to print.

You'll work closely with marketing on briefs and claims, with the commercial team anddistributors on market entry, with finance on costing, and with supply chain on launch.

When you see a risk, you bring a way through it: a reworded claim, a different marketorder, a small formula change. You weigh speed, cost and risk the way an owner would. Youknow which rules are fixed and which leave room for judgement, and you use that room.Two things don't move: our filings are accurate, and our registrations stay in goodstanding.

What you'll own

New products. Our next wave of skincare and haircare launches. Every product passes a Go-Ready check before a purchase order is raised:

• formula frozen
• manufacturer committed
• packaging locked
• landed cost and margin approved
• testing complete
• regulatory cleared
• artwork ready to print

Existing products in new markets. When the commercial team opens a new market, youwork out what it takes to sell there. That means checking whether the formula and claimsare allowed, what the label needs, and which registration or notification applies. You prepare the dossier, including COAs, MSDS, CPSRs and declarations, and you are theregulatory contact for the distributor or local agent until the product is cleared. Recentmarkets include Korea, Australia, and Canada.

Regulatory documents. You're the single contact for the regulatory documents thatdistributors, partners and suppliers ask for, such as COAs, MSDS and declarations. Youkeep a current set for every product, so requests are answered from file rather thanchased.

Formulas and change control. One master formula and one Product Information File foreach product in each market. Nothing about the formula, supplier or pack changeswithout your sign-off.

Manufacturers and suppliers. Choosing and running contract manufacturers andpackaging suppliers. That covers samples, pilots, tech transfer, MOQs, unit cost, and GMPor ISO 22716 status.

Testing. Safety assessments (CPSR), plus challenge, stability, compatibility and microtesting. You plan them onto the critical path, so nothing prints before it clears.

Claims. Substantiation and sign-off for every label, pack and marketing claim.

Registrations. FDA MoCRA registration, listing and safety substantiation; EU and UKnotifications (CPNP and SCPN); Canada; Singapore HSA; China NMPA dossiers; and eachnew market as we enter it. Some you file yourself and some our Responsible Persons orlocal agents file, but you make sure each one is done and kept current.

Partners. Our Responsible Persons, agents, labs and consultants, including their scope,fees and renewals. They handle specific tasks, such as safety assessments, local filingsand acting as our legal representative. You brief them, check what they send back andhold them to dates.

The horizon. Tracking changes to MoCRA, EU 1223/2009, UK rules, CSAR, NMPA andASEAN. You tell the business what each change means for us.

What we're looking for

Commercial sense above all. You've worked closely with marketing or sales, youunderstand margins and launch dates, and you judge yourself on products shipped, notrisks avoided.

At least five years hands-on in regulatory affairs for cosmetics, skincare or personal care.You've prepared the PIF and filed the notification yourself, not just managed the agencythat did it.

Experience running product or launch projects with outside formulators, manufacturersand suppliers. You don't need to be a formulator, but you can keep several projects onschedule and see early when one is slipping.

Working depth in EU and UK cosmetics regulation and US MoCRA, including CPSRs, CPNPand SCPN notifications, and FDA registration and listing.

Experience taking existing products into new markets, ideally in Asia as well as the West.That includes working with distributors and local agents to get products registered.

The ability to read an INCI list, a toxicology report or a stability report critically, and to seewhat's wrong with it.

Judgement on claims. You know where the line between cosmetic and drug sits in the US,EU and Asia, and you can find wording that stays on the right side of it and still sells.

A degree in chemistry, pharmacy, cosmetic science, biology or a related field.

What this role is not

Not a compliance gatekeeper who says no and leaves others to find a way. Not a role thathands work to agencies and waits. You'll do much of the work yourself, own the productsand the regulatory outcomes, and make calls without waiting for a committee.

The arrangement

Based in Singapore, reporting directly to the Group COO of CellResearch Corporation.You'll be close to the founders and the commercial team, not buried in a technical function.