Regulatory Specialist

2 semanas atrás

Rio de Janeiro, Brasil Lonza Tempo inteiro

Brazil, Rio De JaneiroToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

**Key responsibilities**:

- Work with the consultant for the Register/ Revalidation of Finished Goods and Ingredients ANVISA and MAPA as applicable to the CHI business.
- Responsible for monitoring regulatory and compendial changes that impact the business and aiding in action plan development.
- Capture applicable regulatory evolutions, documented via a pragmatic impact assessment and centralized in an overview database, in the applicable domains of CHI products and overall GMP requirements.
- Actively support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance, via maintaining standard customer statements, supporting partnership programs and agreements with strategic and business-relevant customers, and presence at customers for technical or regulatory support where needed.
- Support marketing, BD, R&D, and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing South America regulatory assessments for relevant regulatory topics of interest.
- Responsible for communication with Trend Associations such as SINDUSFARMA, ABIAD, and ABIFISA.
- Regulatory support for customers in South America.
- Approval and Revalidation of local licenses - CRF; MAPA, Local Sanitary Vigilance.
- Work with the consultant on products’ adequacy according to current legislation including Capsules, DFS Products and Ingredients in Human and Animal Health.

**Key requirements**:

- Bachelor's degree in Pharmacy, Regulatory Affairs, Biology, Chemistry, or related field.
- Pos Graduated in progress will be preferred.
- Advanced Portuguese.
- Advanced English Level (B2+, C1 level).
- Advanced Spanish Level.
- At least 4 years of experience with regulatory responsibilities in the pharmaceutical and food / dietary supplement industry for South America.
- Good Microsoft Office knowledge.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.

**Reference: R53926**:

  • Regulatory Affairs Specialist

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Alimentiv Tempo inteiro

    Overview Regulatory Affairs Specialist (LATAM) responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and...

  • Regulatory Affairs Specialist F/m 1

    2 semanas atrás

    Rio de Janeiro, Brasil bioMérieux Tempo inteiro

    A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large...

  • Regulatory Affairs Professional

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatoryAffairs Tempo inteiro R$90.000 - R$110.000

    Enhance public health through innovative solutions in a dynamic regulatory environment.Regulatory Affairs SpecialistThe Regulatory Market team is seeking a skilled Regulatory Affairs Specialist to support Latin America and Canada region. This role involves close collaboration with local teams to ensure product compliance across the region.Key...

  • Compliance Specialist

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$120.000 - R$150.000

    Our company is seeking a highly skilled Technical Regulatory Specialist to join our dynamic team.About the RoleThe primary responsibility of this position will be to ensure that regulatory compliance assessment and monitoring processes are in place, guaranteeing our operations meet the highest industry standards.Key Responsibilities:We require regular...

  • Regulatory Affairs Governance Professional

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeSpecialist Tempo inteiro R$90.000 - R$120.000

    Regulatory Affairs SpecialistThis role requires an individual with a deep understanding of regulatory frameworks and the ability to develop integrated policy and advocacy strategies to drive business objectives. As a Regulatory Affairs Specialist, you will be responsible for creating and executing plans to improve regulatory environments, engage with key...

  • Pharmaceutical Regulatory Specialist

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeDiversity Tempo inteiro R$90.000 - R$123.000

    Regulatory Affairs Analyst RoleAs a key member of our Regulatory Affairs team in Rio de Janeiro, Brazil, you will play a vital role in supporting the management of regulatory priorities and assessments.Key Responsibilities:Support the management in orienting, training, and supervising analysts and trainees in the CRA team and members from the Hub dedicated...

  • Technical Regulatory Specialist

    2 semanas atrás

    Rio de Janeiro, Brasil BW Energy Tempo inteiro

    Ensure that the BWE process of regulatory compliance assessment and monitoring is in place. - Ensure that all operational-related contractors and BWE operations in Brazil are recurrently assessed and monitored regarding regulatory requirements. - Ensure that all activities, for which is under this one responsible, are carried out in conformance with laws and...

  • Regulatory Affairs Specialist

    2 semanas atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Shell Tempo inteiro

    **The Role**:**Company description**As a global energy company operating in a challenging world, we set high standards of performance and ethical behaviors.We are judged by how we act and how we live up to our core values of honesty, integrity, and respect for people.Our Business Principles are based on these.They promote trust, openness, teamwork, and...

  • Regulatory Data Specialist

    Há 6 dias

    Região Geográfica Intermediária de Sorocaba, Brasil Louise Domingues Tempo inteiro

    Regulatory Data Specialist (Mid-Level) – Remote We are building the first global digital regulatory infrastructure, powered by AI, connecting regulators and companies in 20+ countries.If you love data, innovation, and technology, and want to grow with a fast-scaling startup, this role is for you.Location: RemoteContract: Full-time | PermanentWhat you will...

  • Senior Regulatory Expert

    1 semana atrás

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$8.000 - R$12.000

    We're looking for a skilled Regulatory Specialist to join our team as we expand our services.Key ResponsibilitiesAnalyze and ensure compliance with local telecommunication/electronic communication and other relevant regulations;Provide expert regulatory guidance to develop our service offering strategy and country footprint expansion;Collaborate with...