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Regulatory affairs specialist

Castelldefels
PROCARE HEALTH
Publicada el 6 marzo
Descripción

PbWe’re hiring! /b /ppbr/ppAt bProcare Health /b, we are a Spanish pharmaceutical laboratory with an international footprint, dedicated to the research, development, and distribution of bnatural and scientifically proven solutions for women’s health and wellbeing /b. /ppbr/ppWe are currently looking for a bRegulatory Affairs Specialist /b, with a primary focus on bwomen’s health /bfood supplements, and exposure to pharmaceuticals and medical devices. /ppbr/ppbYour mission /b /ppbr/ppYou will support regulatory activities related to food supplements for women’s health, including fertility, menstrual wellbeing, pregnancy support, perimenopause, and menopause, across bEurope and ROW markets /b. /ppbr/ppAs a secondary and optional scope, you may also support selected regulatory activities for bpharmaceuticals and/or medical devices /b, depending on business needs and under supervision. /ppbr/ppbKey responsibilities /b /ppbr/ppbProduct Registration Market Access /b /ppbr/pulliSupport the preparation and submission of food supplement notifications and registrations in the EU and selected ROW markets. /liliAssist with product launches, renewals, and lifecycle management activities. /liliTrack regulatory status, submission timelines, and approvals across multiple geographies. /li /ulpbr/ppbIngredients Formulation Compliance /b /pulliSupport regulatory assessment of formulations containing vitamins, minerals, botanicals, probiotics, and other natural ingredients. /liliAssist in verifying compliance with authorized ingredient lists, maximum levels, country-specific restrictions, and novel food requirements where applicable. /li /ulpbr/ppbLabeling, Claims Product Communication /b /pulliSupport the review of labels, packaging, and marketing materials to ensure regulatory compliance. /liliAssist in the assessment of nutrition and health claims related to fertility, hormonal balance, energy, bone health, and menopause support. /liliCollaborate with Marketing to align compliant claims with brand strategy. /li /ulpbr/ppbSecondary scope - Drugs Medical Devices /b /pulliSupport, under supervision, regulatory documentation for pharmaceutical products and/or medical devices. /liliAssist with registrations, variations, renewals, and compliance maintenance activities. /li /ulpbr/pp bWhat we’re looking for /b /ppbr/pullib3–5 years of experience /b in EU food supplements (preferred). /liliUnderstanding of regulatory requirements in other international markets. /liliBasic knowledge of pharmaceutical and medical device regulatory frameworks is a plus. /liliAbility to interpret regulatory texts and guidance documents. /liliExperience working with external partners (consultants, distributors, manufacturers). /liliStrong attention to detail and compliance-oriented mindset. /liliAbility to manage multiple tasks and regulatory timelines. /lilibFluent English and Spanish /b (written and spoken). Additional languages are an asset. /li /ulpbr/pp bWhat we offer /b /ppbr/pulliA role within a specialized and purpose-driven women’s health company. /liliInternational exposure and meaningful projects. /liliGreat work environment. /liliFlexible start time to better fit your routine (between 8:30 and 9:30 a.m.). /liliRemote work on Fridays from 9:00 a.m. to 2:00 p.m. /liliPrivate health insurance. /liliPermanent contract. /li /ulpbr/pp✨ If you’re passionate about regulatory affairs and women’s health, bwe’d love to hear from you! /b /ppbr/pp Apply now or share this opportunity with your network. /p

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