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How MoCRA Is Creating New Regulatory Affairs Work in the Cosmetics Industry

Connor Griggs (MSRA, CQA)
Connor Griggs (MSRA, CQA)

Regulatory Consultant Providing Expert FDA & EU MDR Project Leadership to Medical Device Companies

9 MIN READ

Introduction

For decades, cosmetics regulation in the United States was famously light. FDA had no authority to require facility registration, product listing, or mandatory recall for cosmetics, and companies were not required to report serious adverse events. That changed with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the most significant expansion of FDA's cosmetics authority since the Federal Food, Drug, and Cosmetic Act itself. For regulatory affairs professionals, MoCRA has quietly created a new category of work: cosmetics and personal care companies that never needed a dedicated regulatory affairs function now do, and companies that already had one are absorbing a meaningfully larger scope of responsibility.

This matters for job seekers and hiring managers alike because it is reshaping where regulatory affairs talent is needed. A field that used to draw almost all of its hiring from pharmaceutical, biologic, and device companies now has a genuine and growing adjacent market in cosmetics and personal care, and the skill set that transfers best is not always the one people expect.

What MoCRA actually requires

MoCRA introduced several obligations that did not previously exist for cosmetics manufacturers marketing products in the US. Facilities that manufacture or process cosmetic products for US distribution must register with FDA, and responsible persons must submit a product listing for each cosmetic product, including its ingredients. Manufacturers must maintain records supporting a "safety substantiation" for each product, meaning adequate evidence that the product is safe for its intended use. Serious adverse events must be reported to FDA within 15 business days, and companies must maintain adverse event records for a set period. The law also directs FDA to issue good manufacturing practice (GMP) regulations for cosmetics, comparable in spirit, though not in scope, to the GMP framework that has long applied to drugs, and it gives FDA mandatory recall authority for cosmetics for the first time. Separately, MoCRA requires new labeling disclosures for fragrance allergens once FDA finalizes the relevant rule, and it directs FDA attention toward talc-containing products and PFAS in cosmetics as specific areas of scrutiny.

None of this makes cosmetics regulation as demanding as the drug or device frameworks. There is still no premarket approval requirement for most cosmetic products. But the shift from essentially no federal registration or reporting obligations to a real compliance framework with recordkeeping, registration, and adverse event reporting deadlines is substantial, and it is not a one-time adjustment. Facility registrations and product listings must be renewed, safety substantiation files have to be kept current as formulations change, and the eventual GMP and labeling rules will add further ongoing obligations once finalized. As with any relatively new statute, some implementing details, including final GMP requirements and fragrance allergen labeling rules, were still working through FDA's rulemaking process as this was written, so companies and candidates evaluating roles in this space should confirm the current status of those specific rules directly with FDA guidance rather than assuming any single point in time is the final picture.

Why this is creating regulatory affairs hiring, not just compliance paperwork

The hiring effect shows up in a few distinct places. First, personal care and cosmetics companies that historically ran compliance through a quality or legal generalist now need someone who can actually track and manage an FDA registration and listing obligation, interpret safety substantiation requirements, and build a defensible adverse event reporting process. That is regulatory affairs work in substance even when the job title on the posting says something more generic like "compliance manager" or "quality and regulatory specialist."

Second, larger consumer products and personal care companies that already had regulatory affairs functions for OTC drug products, medical devices, or dietary supplements are now expanding those teams' scope to cover the cosmetics side of the portfolio, since many companies market both cosmetic and OTC drug versions of similar product lines, such as moisturizers with and without SPF claims, and having one regulatory function cover both is more efficient than maintaining separate teams. That is pulling regulatory professionals with OTC monograph experience into cosmetics-adjacent responsibilities, sometimes for the first time in their careers.

Third, contract manufacturers and private-label cosmetics producers, who now bear direct facility registration obligations under MoCRA rather than being able to rely entirely on brand owners to handle regulatory matters, are building out regulatory capability they did not previously need at all. Smaller and indie beauty brands face a similar dynamic: many are hiring their first regulatory-titled role, or contracting with regulatory consultants, specifically because MoCRA created obligations they cannot manage informally anymore.

What the work actually looks like

Day to day, a regulatory affairs professional working on MoCRA compliance spends time building and maintaining product listings, coordinating with formulation and R&D teams to keep safety substantiation files current as products change, and establishing the internal process for capturing and triaging adverse event reports quickly enough to meet the 15-business-day reporting clock. There is also a meaningful regulatory intelligence component: tracking FDA's cosmetics rulemaking as GMP and fragrance labeling rules move through proposal and finalization, and translating draft requirements into what the company should be preparing for now versus waiting on. Cross-functional coordination with marketing and legal is a bigger part of this work than it typically is in pharmaceutical regulatory affairs, since cosmetics claims review and label compliance intersect with FTC advertising rules in a way that adds another layer beyond FDA's authority alone.

Where the talent is coming from

Companies building out cosmetics regulatory capability are hiring from a mix of sources. Some come directly from OTC drug monograph regulatory backgrounds, since OTC and cosmetics regulatory work share a comparable level of rigor and both require close attention to labeling claims and ingredient-level scrutiny. Others come from quality assurance roles inside personal care manufacturing, where the person already understands the facility and manufacturing side and is adding the regulatory registration and reporting layer on top. A smaller number are pharmaceutical or biologic regulatory affairs professionals making a deliberate move into a less premarket-approval-intensive corner of the field, often for lifestyle or industry-fit reasons, who bring strong regulatory writing and recordkeeping discipline that transfers well even though the specific cosmetics framework is new to them.

What this means if you are evaluating a role in this space

If you are a regulatory affairs candidate considering a cosmetics or personal care opportunity, it is worth asking directly how far along the company is in its MoCRA compliance build-out: whether facility registration and product listing are already complete, whether a formal safety substantiation process exists or still needs to be built, and how adverse event intake currently works. A role at a company still building that infrastructure from scratch will look very different, and often more foundational and process-design-heavy, than one at a company that completed its initial MoCRA compliance work and is now maintaining a steady state. Neither is better than the other, but they call for different strengths, and candidates should be honest with themselves about whether they prefer building a compliance function from the ground up or operating and refining one that already exists.

For regulatory affairs professionals already in pharmaceutical, biologic, or device roles who are simply curious about the adjacent market rather than actively job hunting, MoCRA is worth tracking regardless, since it is a useful live example of how a regulator's authority over a previously lightly regulated product category expands over time, and the compliance patterns look familiar to anyone who has worked through a similar buildout in another part of life sciences.

How this compares to other recent regulatory expansions

Regulatory affairs professionals who have been in the field for a while have seen this pattern before, just in different product categories. Dietary supplements went through a comparable, if not identical, evolution after DSHEA established a framework requiring adverse event reporting and structure/function claim notification for an industry that previously operated with very little federal oversight. OTC monograph reform under the CARES Act similarly modernized a decades-old framework and created new user-fee-funded FDA engagement obligations for OTC drug manufacturers. In each case, the practical effect on hiring was similar: companies that could previously get by without dedicated regulatory affairs staff suddenly needed it, and the professionals who moved fastest into those newly created roles were often people who had already built the underlying skills in an adjacent, more heavily regulated category and were willing to apply them somewhere the compliance bar was still rising rather than already mature.

That pattern is a useful way to think about MoCRA-driven cosmetics roles specifically. The technical subject matter is different from pharmaceuticals or devices, but the underlying regulatory affairs skill set, reading a new statute, translating it into an internal compliance process, and building the recordkeeping discipline to support it, is close to identical. Candidates who can tell that story clearly in an interview, pointing to a prior experience building or scaling a compliance function from an earlier stage, tend to stand out in a cosmetics-sector applicant pool that otherwise skews toward candidates with formulation or brand-side experience but limited regulatory process background.

Conclusion

MoCRA did not turn cosmetics into a premarket-approval industry overnight, and it should not be oversold as such. What it did was create a real, ongoing regulatory affairs function inside an industry that mostly did not need one before, and that shift is visible in hiring patterns across cosmetics manufacturers, contract producers, and the larger consumer products companies that sit adjacent to pharma and OTC drugs. For regulatory affairs professionals looking at where the field is expanding, cosmetics is a smaller market than pharmaceuticals or devices, but it is a genuinely growing one, and it rewards people who already know how to build a compliance function rather than simply operate inside an existing, mature one.

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