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Regulatory Affairs Specialist

3 mesi fa

Milano, Italia Haleon A tempo pieno

Regulatory Affairs Specialist

About the role Are you interested in a Regulatory Affairs role in a dynamic, fast and flexible Company? This role will provide YOU the opportunity to lead key activities to progress YOUR career, joining a collaborative team of regulatory professionals. Your responsibilities include some of the following:

Manage preparation of new regulatory documents, dossiers and applications to enable products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market medicinal products, medical-devices, cosmetics and food supplements. Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated, and obtain the required authorizations where necessary. Analyse regulatory issues and communicate with key stakeholders. Work together to help develop plans to mitigate, so that we can deliver science that is robust and aligned with business needs. Support key processes related to CMC, quality, labelling, artworks and local regulations. Actively contribute to high-performing local teams, seeking continuous performance improvement. Maintain required regulatory compliance databases, systems and processes. Maintain high level of knowledge on the science of products within defined portfolio. Qualifications & Skills Relevant previous experience of at least 3 years in a pharmaceutical/healthcare company, preferably multinational. Good knowledge of pharmaceutical laws and regulation and fluent management of the life cycle management. Knowledge of the fundamentals of cosmetic, medical devices and food supplement laws and regulations. Scientific Degree (Pharmacy, Pharmaceutical chemistry, Chemistry or related disciplines). Master in Regulatory Affairs is preferred. Fluent in English. Ability to use Microsoft Word, Excel, PowerPoint and Adobe. Preferred Good team player, with strong interpersonal skills to work well in cross-functional teams. Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods. Results-driven mindset, with the ability to work in a fast-paced, dynamic environment. Good attention to detail and problem-solving skills within a structured process. Organizational and time management skills, with ability to manage multiple priorities and meet tight deadlines. Diversity, Equity and Inclusion 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 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.

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