Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer page is loadedSenior Regulatory Affairs OfficerApply locations Lisbon time type Full time posted on Posted 14 Days Ago job requisition id 526976Hello. 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.About the roleHaleon Portugal is looking for a Regulatory Affairs Officer Position belonging to the R&D department and reporting to the Portugal Regulatory Affairs Lead.Importance of the function within the company:Regulatory affairs play a crucial role in the consumer healthcare sector where Haleon operates. This function ensures compliance with all relevant laws and regulations, including local, national, and international standards, which helps avoid legal issues, fines, and penalties.Regulatory affairs professionals are responsible for obtaining the necessary registrations and approvals to bring new products to market, involving license maintenance activities and regulatory compliance for medicinal and non-medicinal products. They also ensure that product labelling and advertising are accurate and comply with regulatory standards, maintaining consumer trust and avoiding misleading claims.Additionally, regulatory affairs work closely with quality assurance teams to ensure that manufacturing processes meet regulatory standards, helping maintain product quality and consistency. A strong regulatory affairs team can provide a strategic advantage by ensuring faster approval times and smoother market entry, which can be a significant competitive edge in fast-moving industries.After a product is on the market, regulatory affairs continue to monitor its performance, tracking adverse events, updating labelling, and ensuring ongoing compliance with regulations.They also act as a bridge between the company and regulatory bodies, communicating with other stakeholders, including healthcare professionals, consumers, and internal teams, to ensure everyone is informed about regulatory requirements and changesKey responsibilitiesDossier Preparation and Submission: Prepares and submits dossiers to the Portuguese Health Authorities for medicines, cosmetics, medical devices, and food supplements.Regulatory Communication: Manages communication with Portuguese Health Authorities and Competent Authorities for various product categories.Medicines life cycle management: Oversees renewals, variations, new product launches, and variation implementation projects.Scientific and Regulatory Documentation: Develops and submits scientific information for OTC classification, elaborates SmPCs, leaflets, and artworks, and coordinates with Global and Category Regulatory teams for dossier submissions.Support and Compliance: Provides regulatory strategy and claims support to Local Business and Global RA, supports marketing with strategic information, and ensures compliance with legislation and internal processes.Artwork and Promotional Material Review: Revises and approves artworks, provides input for advertising campaigns, claims and strategy, while maintaining awareness of relevant legislation.Compliance with internal processes and procedures and maintenance of key databases.Administrative support activities: national product codes, notification of promotional materials and events.Non exhaustive list of brands to be managed: Nasal (Vibrocil, Rhinomer) Cold and Flu (Panadol Gripus, PanaTosse), Skin (Fenistil, Zovirax, Zovirax Duo), Oral Care (Sensodyne, Parodontax and Corsodyl, Pain (Voltaren 24H patches), Food Supplements (Centrum).Qualifications and skillsEssentialLicense degree or Integrated MasterLife science/Pharmaceutically related science (Pharmacy, Pharmaceutical science)Excellent knowledge of spoken and written EnglishExcellent knowledge of office IT toolsGeneral knowledge of pharmaceutical industryGood knowledge of Portuguese pharmaceutical, cosmetic, medical device and food supplements legislationGood knowledge and relationship with Health AuthoritiesPreferredEffective communication.Excellent capability of critic and analytical thinking.Attention to detail.Project management experience.More than 5 years of experience in similar role.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/At 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.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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.Who are we?Hello. We'reHaleon. A new world-leading consumerhealthcare company. Shaped by all of us. Together, we'reimproving everyday health for millions of people. Bygrowing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil,Voltaren, Theraflu,Otrivin, and Centrum - through aunique combination of deep human understanding andtrusted science. What's more, we're achieving it in acompany that we're building together. In an environmentthat we're co-creating. And a culture that's uniquelyours. Care to join us. It isn't a question.

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