Regulatory Affairs Project Manager

ppSelect how often (in days) to receive an alert: /p /brpAt Perrigo, we are driven by our mission to bMakes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All /b. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing bThe Best Self-Care for Everyone /b, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. bWe Are Perrigo /b. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. /p /brpJoin us on our One Perrigo journey as we evolve to win in self-care. /p /brh3bDescription Overview /b /h3 /brpAre you an experienced Regulatory Affairs Project Manager with business acumen and a keen eye for detail? We are looking for a new colleague to reinforce the regulatory activity required to submit, approve and launch new products and the maintenance of existing commercialized products and dossiers. In this role, you will be a key advisor to internal teams and external stakeholders, contributing to successful product registrations and market access projects, promotional campaigns, and protection of existing products in a fast changing regulatory environment. /p /brh3bScope of the Role /b /h3 /brul /brliAssist in execution of regulatory activities per the project plan to assure new products meet submission, approval and commercial launch goals. /li /brliHighly involved in the products’ lifecycle, including New Product Development (NPD) and launches, lifecycle maintenance and promotional activities. /li /brliSupport manufacturing and procurement in the management of change to existing commercial products. /li /brliMaintain product labeling in compliance with local and EU laws and regulations; develop and approve label specifications in compliance with SOPs. /li /brliSupport the development and approval of packaging materials in a timely manner. /li /brliProcess change requests in compliance with GMPs and regulations. /li /brliMaintain regulatory files and data systems in compliance with SOPs. /li /brliEnsure timely and effective communication and collaboration with other departments including marketing, CSI (trade marketing), sales and corporate regulatory and innovation. /li /brliReview technical documentation and manage regulatory submissions in a timely manner. /li /brliProcess feedback from regulatory authorities and notified bodies. /li /brliSupport the development and clearance of promotional materials. /li /brliProvide input for analysis of data and/or management review, if required. /li /brliAssist in the process of reporting and investigating critical non-conformities and opportunities for improvement. /li /br /ul /brh3bExperience Required /b /h3 /brpMaster’s degree in Life Sciences, Foods, Pharmacy, or a related field /p /brul /brliAt least 4 years of experience in Regulatory Affairs /li /brliIn-depth knowledge of local and EU regulations; at least in one of the countries of the Benelux and one or more of the following regulatory frameworks: medicines, medical devices, food supplements, biocides, general health products or cosmetic products. /li /brliStrong communication and project management skills /li /brliThe ability to work both autonomously in local and international teams /li /brliStrong communication, persuasion and problem-solving skills, with the ability to translate regulatory complexity to non-regulatory employees /li /brliCuriosity - An eager and quick learner willing to develop and improve /li /brliFluent in Dutch and English is a must; knowledge of French and German is an asset /li /br /ul /brh3bBenefits /b /h3 /brpWe believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. /p /brh3bHybrid Working Approach /b /h3 /brpWe love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. /p /brpWe are proud to be included in the Forbes list of \"America's Best Employers by State 2024\". Find out more here /p /brpWe are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo /p /p #J-18808-Ljbffr