Sr Regulatory Affairs Associate
Há 6 dias
Description Position: Regulatory Affairs Sr. Associate in São Paulo, Brazil We are looking for a regulatory affairs professional who is passionate about biotechnology and with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an opportunity to join the Regulatory Affairs team built on a strong sense of teamwork and excellence. This position is based in Sao Paulo reporting to the Director of Regulatory Affairs. The successful candidate will lead the regulatory maintenance of Gilead´s current portfolio working close to local and international areas such as CMC, Supply Chain, Quality Assurance and others. As such, the role involves close cross-functional collaboration and requires a high sense of urgency, negotiation skills and organization. Essential Duties and Responsibilities include the following: As an individual contributor you will: Support the definition, development and execution of regulatory strategies for maintenance of registered products, including variations, line extensions, labelling updates, renewals and annual reports. Manage GMP applications and renewals; maintenance of legal documents (operating license and CRF); Manage labeling and artwork updates; Support monitoring competitors as part of the regulatory intelligence activities; Provide proper regulatory advice to main stakeholders considering business needs and assuring no commercialization disruption due to variations, as applicable; Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) in order to keep the internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects. Lead internal discussions and projects to support public consultations to capture Gilead´s contributions for shaping the regulatory environment and, for new regulations, support and assure the implementation of Brazilian requirements; Review and approve promotional and non-promotional materials according with local regulations, ethics code and Gilead´s business conduct. Support local processes improvements and contributes to local and/or global processes improvements which have a significant impact for RA and other departments; assess proposed changes to local procedural documents and impact on existing process. Education & Experience: Pharmacist / Biochemistry degree; Extensive experience in the pharmaceutical/biotechnology industry and in particular R&D companies; Fluent in English; Extensive knowledge and proven experience on post-registration changes / line extensions / labeling updates regulations, including the new API framework. Extensive experience in small molecules regulation and desirable experience in biologics regulations. Experience in developing and implementing regulatory requirements and complex regulatory strategies. Skills & Behaviors Sense of urgency and priorities. Self-motivator, enthusiastic, tenacious and energizing. Proactive and open to share, advise and educate colleagues across the organization. Agile in an evolving environment. Resilient with the ability to influence and deliver in an ambiguous environment. Ability to engage stakeholders and manage multiple stakeholders to achieve the objective. Excellent verbal & written English, negotiation, influence and interpersonal communication skills A good team player. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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Sr Regulatory Affairs Associate
1 semana atrás
São Paulo, Brasil Gilead Sciences Farmaceutica do Brasil Ltda Tempo inteiroDescription Position : Regulatory Affairs Sr. Associate in São Paulo, Brazil We are looking for a regulatory affairs professional who is passionate about biotechnology and with creative problem-solving skills to seamlessly meet the business needs while maintaining regulatory compliance. This is an opportunity to join the Regulatory Affairs team built on a...
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Sr Regulatory Affairs Associate
4 semanas atrás
São Paulo, Brasil Gilead Sciences Tempo inteiroAt Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission...
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Sr Regulatory Affairs Associate
Há 3 dias
São Paulo, Brasil Getting Hired Tempo inteiroAt Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges,...
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Sr Regulatory Affairs Associate
1 semana atrás
São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiroAt Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our...
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Sr Regulatory Affairs Associate
1 dia atrás
São Paulo, Brasil Gilead Sciences, Inc. Tempo inteiroAt Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges,...
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Junior Regulatory Affairs Associate
Há 6 dias
São Paulo, Brasil Parexel Tempo inteiroThe Junior Associate assists in the assembling of submissions (low complexity post-approval changes in CTD or non-CTD format such as leaflet and packaging notification, administrative changes, renewals, support with Annual Reports activities, support with CMC changes and GMP Renewals for vaccines, biological products and small molecules) and delivery of...
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Junior Regulatory Affairs Associate
Há 5 dias
São Paulo, Brasil Parexel Tempo inteiroThe Junior Associate assists in the assembling of submissions (low complexity post-approval changes in CTD or non-CTD format such as leaflet and packaging notification, administrative changes, renewals, support with Annual Reports activities, support with CMC changes and GMP Renewals for vaccines, biological products and small molecules) and delivery of...
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Regulatory Affairs Associate
1 semana atrás
São Paulo, São Paulo, Brasil Teleflex Tempo inteiroAbout Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and...
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Associate Manager, Regulatory Affairs
2 semanas atrás
São Paulo, Brasil BeiGene Tempo inteiroPLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATIONLocation: Sao Paulo HybridLanguage Requirement: English required and Spanish is a plus.Required Experience: Pharmaceutical/Biotech IndustryGeneral Description:This position will be responsible for coordinating the drug registration process in timely and efficiently from beginning to end in accordance...
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Regulatory Affairs Intern
Há 19 horas
São Paulo, Brasil Edwards Lifesciences Tempo inteiro**How you'll make an impact**: Support the Regulatory Affairs LATAM (Latin America) team by performing activities such as: - Preparation of documentation for regulatory submissions - Requesting legal documents - Processing Regulatory Affairs suppliers payments requests - Tracking timelines and document milestone achievements - Interacting with different...
