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Sr. regulatory affairs specialist

Galway
Cpl Healthcare
Regulatory affairs specialist
Posted: 23 April
Offer description

I'm partnering with an international health & wellness company to hire a
Senior Regulatory Affairs Specialist
for their EMEA business.
This is a permanent role based in Athenry, Co.
Galway, with the option to move to a hybrid set-up after probation (6 Months).
You'll be the key regulatory contact on the ground in Ireland, working across a really interesting mix of products – food supplements, cosmetics, medical devices and general wellness products, and helping to make sure they can be launched and sold compliantly in multiple markets.
The opportunity
In this role, you will:
Own day-to-day regulatory activities for EMEA markets to support product launch and maintenance.
Review ingredients, labels and marketing materials to make sure they meet local requirements for food supplements, cosmetics, devices and wellness products.
Investigate regulatory requirements in new markets (for example, what's needed to launch a cosmetic or supplement in Australia) and coordinate with internal teams and external consultants.
Help answer product-related queries from internal teams and regulators, and make practical recommendations on what is and isn't possible.
Maintain regulatory tools/trackers and support change control and sign-off on promotional and labelling materials within agreed parameters.
Communicate clearly with stakeholders (quality, marketing, sales, operations) so they understand why certain ingredients, claims or timelines are constrained in specific countries.
What they're really looking for
Someone with strong hands-on experience inEuropean food supplement and/or cosmetic regulations, this is the biggest priority right now.
A regulatory professional who is comfortable working across multiple product categories and jurisdictions, and who is happy to research, interpret guidance and speak to consultants when the answer isn't obvious.
A self-sufficient person who can make sound decisions day-to-day, while still knowing when to loop in the wider global RA team.
The rest of the RA team is US-based (Mountain Time), so you'll often be the only RA presence in your timezone.
About you
4–6+ years' regulatory affairs experience in one or more of: food supplements, cosmetics, medical devices, or related regulated consumer health products in EMEA.
Strong understanding of EU regulations for food supplements and/or cosmetics; experience with country-specific nuances is a real advantage.
Comfortable working with marketing and commercial teams, explaining regulatory constraints and helping them find compliant solutions.
Excellent attention to detail, time management and organisational skills, you can juggle multiple projects and stay calm when timelines tighten.
Confident communicator who can work independently but also collaborate with colleagues in the US and across EMEA.
Proficient with Microsoft Office and general regulatory documentation tools.
Please apply directly or share your CV with ******.
#J-*****-Ljbffr

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