REGULATORY SENIOR ANALYST

Nosso time At Opella, our mission is to transform science into simple solutions that put the patient at the center of everything we do.
We believe that self-care is a powerful tool for promoting health and well-being.
With a focus on OTC (Over-the-Counter) medications and dietary supplements, we are dedicated to creating products that make daily personal care easier, making science accessible and a part of people's everyday lives.
Principais Responsabilidades - Collaborate with Global Functions, R&D, Quality Assurance, Marketing, and other departments to ensure regulatory requirements are considered in product development and post-market activities; - Provide regulatory guidance to support changes to existing products; - Assist in the preparation and submission of regulatory documents to Health Authorities; - Track and manage submission timelines to ensure timely approvals and escalate any possible risk to local and global teams; - Work collaboratively with relevant stakeholders to identify solutions and mitigate potential impacts on timelines or project objectives; - Implement a comprehensive regulatory strategy that aligns with project objectives and local regulatory requirements, considering timelines, risks, and potential challenges; - Participate in the evaluation of promotional materials, ensuring they comply with current legislation and internal procedures; - Update the company's systems and databases; - Manage the artwork approval process through the internal system; - Establish and maintain positive relationships with regulatory authorities in Brazil; - Act as a point of contact with regulatory agencies, responding to inquiries and requests for additional information; - Contribute to influencing regulatory bodies and health authorities by actively participating in meetings/committees and building relationships to review and update legislation, assess business impacts, and provide clarifications on projects and products; - Promote compliance with internal processes, metrics, and controls, focusing on portfolio registrations and their maintenance.
Colaboradores individuais The mission of the Senior Regulatory Analyst is to assist in navigating and facilitating the regulatory landscape, ensuring that the company’s products comply with all applicable laws and regulations while supporting business objectives.
Contribute to the preparation and submission of dossiers, respond to inquiries from regulatory authorities, and obtain the necessary approvals for product marketing and distribution.
Provide support to global and local functions.
This role requires a solid understanding of regulatory frameworks, strong communication skills, and the ability to collaborate with various functions within the organization.
Additionally, ensure that internal projects progress efficiently and achieve regulatory compliance within the required timelines.
Sobre você Bachelor’s degree in Pharmacy, Life Sciences, or a related field.
Minimum experience of 3 years in Regulatory Affairs, preferably within the pharmaceutical industry.
Proven experience in LCM and dossier preparation for regulatory submissions.
Strong knowledge of regulatory frameworks and requirements in Brazil; Ability to work collaboratively with cross-functional teams, including R&D, Marketing, Quality, and other departments.
Excellent organizational skills with the ability to manage multiple projects and timelines simultaneously.
Fluent English is required.
Persiga o progresso, descubra o extraordinário O melhor está lá fora.
Melhores medicações, melhores resultados, melhor ciência.
Porém o progresso não acontece sem pessoas – pessoas de diferentes origens, em diferentes localizações, em diferentes posições, todas juntas para um propósito.
o desejo de fazer milagres acontecerem.
Então, vamos ser essas pessoas.
Na Sanofi, nós provemos oportunidades iguais independentemente da raça, cor, ancestralidade, religião, sexo, nacionalidade, orientação sexual, idade, cidadania, estado civil, deficiência ou identidade de gênero.
Assista o nosso ALL IN video e veja as ações de igualdade de diversidade e inclusão na sanofi.
om! *Sempre visando a segurança e bem-estar de nossos colaboradores, o comprovante de vacinação COVID 19 é um item imprescindível para todos os empregados, estando presente na lista de documentos de admissão.
“ #LI-LATAM En Sanofi, la diversidad e inclusión son fundamentales para nuestro funcionamiento y son parte importante de nuestros Valores.
Reconocemos que para aprovechar verdaderamente la riqueza que aporta la diversidad, debemos liderar con inclusión y tener un lugar de trabajo donde esas diferencias puedan ser aprovechadas para potenciar la vida de nuestros colegas, pacientes y clientes.
Respetamos y fomentamos la diversidad de nuestra gente, sus antecedentes y experiencias, y brindamos igualdad de oportunidades para todos.
En Sanofi nos dedicamos a apoyar a las personas en sus problemas de salud.
Somos una empresa biofarmacéutica global centrada en salud humana.
Prevenimos enfermedades gracias a las vacunas y proporcionamos tratamientos innovadores para combatir el dolor y reducir el sufrimiento.
Acompañamos tanto a los pocos que padecen enfermedades raras como a los millones de personas que viven con patologías crónicas.
Con más de personas en 100 países, Sanofi está transformando la innovación científica en soluciones para la salud de las personas de todo el mundo.
Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life.
We are constantly moving and growing, making sure our people grow with us.
Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube