Faça parte de algo maior na BD. Aqui, você nos ajudará a manter nossos altos padrões de uma perspectiva regulatória em todos os níveis, com foco nas submissões. Requer atenção aguda aos detalhes, excelentes habilidades de comunicação e uma paixão para continuar aprendendo e atualizando seu conhecimento, o que o ajudaremos a fazer com oportunidades regulares de aprendizado. Aqui, você usará seu profundo conhecimento das regulamentações e requisitos da FDA, Canadá e ISO/MDD em torno de dispositivos médicos para atingir um objetivo único: Impulsionar o mundo da saúde™. Na BD, você pode fazer a verdadeira diferença de um.
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Job Description Summary
As International Regulatory Affairs Specialist you will be responsible of prepare and write registration files for pharmaceutical products to be submitted in the targeted markets for Infection Prevention Portfolio, maintain and protect existing licenses in international, ensuring compliance with local regulations orreview and approve change control / design control impacting packaging and artworks to ensure regulatory compliance.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become amaker of possiblewith us!
Our vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.
About the role
As International Regulatory Affairs Specialist you will have the following responsibilities:
- Prepare and write registration files for pharmaceutical products to be submitted in the targeted markets for Infection Prevention Portfolio.
- Maintain and protect existing licenses in international, ensuring compliance with local regulations.
- Review and approve change control / design control impacting packaging and artworks to ensure regulatory compliance.
- Ensure that the pharmaceutical products sold in international meet the local regulatory requirements and support the local registration of these products in a professional, compliant and timely manner.
- Liaise with the Infection Prevention team (local office or local distributors, manufacturing, quality, R&D, regulatory) to ensure effective registrations.
- Provide timely support when requested by these organizations in preparing necessary registration documents, submitting these documents in a timely manner and maintaining an adequate archiving system.
- Maintain the database in which all registrations made in these territories are documented.
- Pro-actively follow up on product registrations and ensure that post-market obligations are met in the territories covered by the business.
- Maintain knowledge of specific regulatory requirements for targeted markets.
About you
- University degree or equivalent experience.
- Experience in regulatory in the pharmaceutical industry. Experience in preparation, review and submission of labeling variations is a plus.
- Proficient English level.
- Knowledge of the development, manufacturing and marketing of pharmaceutical products and the application of technical CMC and GMP principles.
- Experience working with multifunctional and multicultural groups, including international regulatory agencies is a plus.
- Must be detail oriented with excellent organizational skills with the ability to analyse regulatory documents (e.g. registration files)
- Ability to read professional journals, technical procedures or governmental regulations. Ability to write reports, registration modules and procedure manuals.
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit:https://bd.com/careers
Required Skills
Optional Skills
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Primary Work Location
ESP San Agustin del GuadalixAdditional Locations
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Perfil de Sucesso
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analítico
- Colaborativo
- Comunicador
- Persuasivo
- Solucionador de problemas
- Apresentador habilidoso
Impulsionando o mundo da saúde™
BD é uma das maiores empresas globais de tecnologia médica do mundo e está Impulsionando o mundo da saúde™ melhorando a descoberta médica, o diagnóstico e a entrega de cuidado. A BD ajuda os clientes a melhorar os resultados, reduzir custos, aumentar a eficiência, melhorar a segurança e expandir o acesso aos cuidados de saúde.