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Analista de Assuntos Regulatórios Sr
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As an Analyst you will be part of the the Regulatory Affairs team in our Healthcare division, responsible for process from Brazil, reporting to our regional and global management.
Your role will be:
Works with a high level of autonomy with the following scope of activities:
- Support the management in the orientation, training and supervision of the analysts and trainees of CRA team and members from Hub dedicated to BRA activities;
- Support the local and regional regulatory teams in establishing regulatory priorities and assessments;
- Support in the preparation, submission and review of the applications done by regional regulatory team whenever needed;
- Support the areas as a regulatory focal point, representing the management;
- Support the management in the "Regulatory News" revision and all matters related to regulatory intelligence;
- Keep abreast and disseminate regulatory legislations;
- Prepare and make submissions to authorities in order to obtain and maintain approval of product registration, post-registration and registration renewals, according to legal and/or internal deadlines;
- Develop and write clear and robust arguments and explanations for any applications;
- Develop regulatory strategies and implementation plans for the preparation and submission of new products;
- Implement and update the corporative regulatory information management system (Veeva);
- Provide regulatory assessment of change controls;
- Provide regulatory assessment of packaging materials and labels, keeping the Product Information of all products updated at Health Authorities, mainly safety information, according to legal and/or global/internal deadlines;
- Elaborate and submit the Product Information of all new products to be registered by the company;
- Follow up Product Information of competitors and of reference medicines for generics and branded generics;
- Follow-up on ANVISA's queue of analysis;
- Support the preparation of the report of competitors to share with Commercial teams;
- Provide advice about regulatory requirements and regulations to local and global teams and partners;
- Lead and participate in phone conferences and meetings with local / regional / global teams and partners;
- Liaise with, and make presentations to local / global teams and partners;
- Keep up-to-date with changes in regulatory legislation and guidelines;
- Do all the trainings signed to (e.g. Veeva, others as appropriate);
- Assist the Pharmacovigilance area, providing regulatory information for the PBRERs elaboration and submitting the reports to HA;
- Assist Consumer Service to answer client's questions
Who you are:
- Graduation in Pharmacy and Post-Graduation;
- Vast experience from pharmaceutical industry from a Regulatory Affairs perspective, including elaboration and submission of marketing authorization and LCM applications;
- Deep knowledge of Brazilian pharmaceutical legislation, relevant guidelines, procedures and requirements;
- Experience in Clinical Research, Pharmacovigilance, Production, Quality Assurance, Research and Development is an advantage;
- Vast experience in Health Authority and Trade Associations interactions.
- Fluent oral and written English;
- Intermediate Spanish is an advantage.
- Jacarepaguá - Rio de Janeiro/RJ (Hybrid - 3 days at the office)
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!