Senior Regulatory Affairs Officer

Detalhes da Vaga

.Hello. 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. About the role Haleon 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. 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 changes. Key responsibilities Dossier 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


Salário Nominal: A acordar

Fonte: Jobtome_Ppc

Função de trabalho:

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