Regulatory Affairs Specialist - PROCARE HEALTH
hace 3 días
Castelldefels
We’re hiring! At Procare Health, we are a Spanish pharmaceutical laboratory with an international footprint, dedicated to the research, development, and distribution of natural and scientifically proven solutions for women’s health and wellbeing. We are currently looking for a Regulatory Affairs Specialist, with a primary focus on women’s health food supplements, and exposure to pharmaceuticals and medical devices. Your mission You will support regulatory activities related to food supplements for women’s health, including fertility, menstrual wellbeing, pregnancy support, perimenopause, and menopause, across Europe and ROW markets. As a secondary and optional scope, you may also support selected regulatory activities for pharmaceuticals and/or medical devices, depending on business needs and under supervision. Key responsibilities Product Registration & Market Access • Support the preparation and submission of food supplement notifications and registrations in the EU and selected ROW markets., • Assist with product launches, renewals, and lifecycle management activities., • Track regulatory status, submission timelines, and approvals across multiple geographies. Ingredients & Formulation Compliance • Support regulatory assessment of formulations containing vitamins, minerals, botanicals, probiotics, and other natural ingredients., • Assist in verifying compliance with authorized ingredient lists, maximum levels, country-specific restrictions, and novel food requirements where applicable. Labeling, Claims & Product Communication • Support the review of labels, packaging, and marketing materials to ensure regulatory compliance., • Assist in the assessment of nutrition and health claims related to fertility, hormonal balance, energy, bone health, and menopause support., • Collaborate with Marketing to align compliant claims with brand strategy. Secondary scope - Drugs & Medical Devices • Support, under supervision, regulatory documentation for pharmaceutical products and/or medical devices., • Assist with registrations, variations, renewals, and compliance maintenance activities. What we’re looking for • 3–5 years of experience in EU food supplements (preferred)., • Understanding of regulatory requirements in other international markets., • Basic knowledge of pharmaceutical and medical device regulatory frameworks is a plus., • Ability to interpret regulatory texts and guidance documents., • Experience working with external partners (consultants, distributors, manufacturers)., • Strong attention to detail and compliance-oriented mindset., • Ability to manage multiple tasks and regulatory timelines., • Fluent English and Spanish (written and spoken). Additional languages are an asset. What we offer • A role within a specialized and purpose-driven women’s health company., • International exposure and meaningful projects., • Great work environment., • Flexible start time to better fit your routine (between 8:30 and 9:30 a.m.)., • Remote work on Fridays from 9:00 a.m. to 2:00 p.m., • Private health insurance., • Permanent contract. ✨ If you’re passionate about regulatory affairs and women’s health, we’d love to hear from you! 👉 Apply now or share this opportunity with your network.
