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Regulatory Affairs Associate

Regulatory Affairs Associate
Empresa:

Haleon


Detalles de la oferta

**Job Description**:**Site Name**: Costa Rica - Cartago - Tres Rios**Posted Date**: Feb 27 2023Hello. 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.**Your Responsibilities**:This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:- Analyze 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.- Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance.- Build relationships with key stakeholders and represent Haleon in an appropriate manner according to company values, policies and strategies.- Manage compliance within defined portfolio/activity streams in line with Haleon expectations - support key processes and ways of working (e.g., in relation to Haleon CMC, quality, product labeling requirements as well as local MoH regulations).- Work together with other areas (e.g., marketing, supply chain, project management) to deliver NPD and value engineering projects.- Correct handling and timely updating of regulatory systems such as Veeva Regulatory, local databases, and other systems with regulatory information with high impact to the business.- Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.- Proactively manage impact of regulatory changes within defined scope of responsibility on the business.- Ensure the required regulatory compliance databases, systems, and processes.- Actively participate in sessions regarding new projects and provide accurate regulatory feedback.- Plan, determine and establish the correct regulatory strategy for NPI/innovation projects and according to the business needs.- Take active involvement, reviewing legislation in countries, when public consultation periods are opened for new tentative changes in legal frames and regulatory policies of medicines, cosmetics, food supplements and medical devices.- Ensure and support maintenance of the SAP system with the regulatory information for the invoicing of the products under my responsibility to the countries of the region (dates, description, license number)- Responsible in artwork harmonization process for the region, and its internal approval and HA approval, to homologate artworks for Caricam.- Support the process improvement for local SOPs, according to the established role, in accordance with Haleon policies and global/local SOPs simplification.- Proactively participate in the activities of the CoPI (community of practice) to find ways to increase the chances of success in the RA processes or in good regulatory practices.**Why you?****Basic Qualifications**:We are looking for professionals with these characteristics to achieve our goals:- Pharmaceutical degree needed as required by local regulations.- Experience 3-5 years in similar position.- Intermediate / Advanced English level.**Preferred Qualifications**:However, if you have the following, it would be a plus:- Active member of Colegio de Farmacéuticos.- Previous experience in regulatory affairs for: Central America, Panama, Dominican Republic, Aruba, Curacao, Trinidad & Tobago, Jamaica.- Experienced in portfolio management or registrations in categories: cosmetics, nutritional supplements, medical devices.**Inclusion & Diversity at Haleon**: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.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 s


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Requisitos

Regulatory Affairs Associate
Empresa:

Haleon


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