Regulatory Compliance SupervisorHello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.The main objective is to coordinate activities with a regulatory impact on a portfolio of products by ensuring regulatory compliance during the lifecycle of the product, participating in projects evaluation and submission strategy.ResponsibilitiesResponsible for planning the site’s regulatory activities for the products under his responsibility and for new developments projects. Collaborate with Central Regulatory on the establishment of planned activities (variations, renewals,…) and prioritization. Escalate potential issues or delays.Ensure timely availability of documentation for planned regulatory submissions and RTQ, act as facilitator between Central Regulatory and plant technical functions (production, technical, engineering and analytical/stability departments) and collaborate with worldwide affiliates for regulatory compliance matters.Evaluate regulatory relevance of proposed changes. Participate in change control process from creation, strategy and implementation until closure, represent regulatory point of view at the site’s Change Control Committee.Prepare documentation to support layouts/process/personnel flow and equipment changes to be authorized by Health Authorities (e.g. AIFA or ASL) through the collaboration with plant technical functions (production, technical, engineering and analytical/stability departments).Prepare documentation to keep updated all plant GMP licences.Identify and evaluate gaps as well as propose regulatory remediation and get escalation process under way in case of non-compliance.Regulatory Compliance SME during audits and Health Authorities Inspections.Regulatory Compliance SME for all products manufactured by site in terms of compliance to central and local regulations (QRI).Compliance SME for dietary supplements (HACCP, allergens).Elaborate SOP and WI for all processes related to team activities and daily tasks.Coordinate ways of working with other departments and work on process improvement.Qualifications and skillsBiological sciences, Chemistry, Pharmacy or related scientific discipline5-7+ years in a Pharmaceutical Quality Environment. Good experience in Regulatory Affairs/CMC. Understanding of laboratory techniquesGood understanding of GMP/HACCPEnglish: fluent (oral and written), good presentation skillsMS Office: good commandM-ERP, Veeva: good knowledgeTeam player, ability to analyse and attentive to details, good communication and influencing skills, handling of priorities, adaptability.Diversity, Equity and InclusionAt Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Accommodation RequestsIf you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.
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