Regulatory Affairs Analyst

4 meses atrás


Santo Amaro, Brasil Novartis Tempo inteiro

**Summary**:
The Regulatory Affairs Analyst will be responsible for contributing and supporting regulatory activities related to post-approval changes for products within the organization. This position involves ensuring compliance with regulatory requirements for changes made to approved products and collaborates with cross-functional teams to prepare and submit required documentation to HA.

**About the Role**:
**Major accountabilities**:

- Prepare and submit post-approval changes (CMC variations) to HA, including dossier review and strategy definition.
- Conduct regulatory evaluation of post-approval changes to assess their impact and ensure adherence to relevant guidelines and legislations.
- Collaborate with cross-functional teams to define project timelines and provide information on regulatory requirements for submissions.
- Review less complex post-approval change dossiers
- Maintain and update area databases, ensuring all information and documentation is accurate and up-to-date.
- Support in reviewing and updating labeling material and ensuring compliance with HA requirements
- Participate in meetings with minor and moderate impact at trade associations
- Provide regulatory guidance and support to cross-functional teams during the development and implementation of post-approval changes.

**Minimum Requirements**:
**Work Experience**:

- Bachelor's degree in Pharmacy or related courses.
- Prior experience working in the regulatory affairs area of Pharmaceutical Industry
- Detail-oriented and highly organized, capable of managing multiple projects simultaneously

**Languages**:

- Advanced English language proficiency.

**You’ll receive**:
Competitive salary, annual bonus, pension scheme, life insurance, 30 days annual leave, year-end recess, hybrid work model (home office 2x a week), flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, free parking lot (Santo Amaro and Cambe), Gympass, Space Energized for Life, gym (Santo Amaro) and virtual self-development tools.

**Imagine what you could do at Novartis**

Division

Development

Business Unit

Innovative Medicines

Location

Brazil

Site

Santo Amaro

Company / Legal Entity

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No


  • Rwe Study

    7 meses atrás


    Santo Amaro, Brasil Novartis Tempo inteiro

    **Summary**: Modelo de Trabalho: Híbrido Localidade: São Paulo Sobre essa vaga: Estamos procurando um RWE Study & MAP Operation Analyst para nos ajudar a permanecer entre as principais empresas farmacêuticas do mundo, sempre buscando levar produtos inovadores aos pacientes de forma rápida e eficaz. Como uma empresa global, os recursos e as oportunidades...


  • Santo Amaro, Bahia, Brasil Novartis Farmacéutica Tempo inteiro

    Novartis Farmacética is seeking a highly skilled and experienced medical professional to join our team as a Senior Medical Leader for Early Launches.About the RoleThe ideal candidate will be responsible for providing medical leadership and expertise to support the launch of new products in Brazil. This will involve working closely with cross-functional...


  • Santo Amaro, Brasil Healthcare Businesswomen’s Association Tempo inteiro

    Job Description SummaryMedical leader for pipeline products. Gather healthcare system and stakeholders’ insights, develop and lead the execution of medical plan during the early launch timeframe for products/indication/therapeutic area under responsibility.Job DescriptionKey responsibilities:Ensure medical enquiries are responded to in a high quality,...


  • Santo Amaro, Brasil Novartis Farmacéutica Tempo inteiro

    Medical leader for pipeline products. Gather healthcare system and stakeholders’ insights, develop and lead the execution of medical plan during the early launch timeframe for products/indication/ therapeutic area under responsibility.About the Role Key responsibilities:Ensure medical enquiries are responded to in a high quality, timely manner, and in...


  • Santo Amaro, Brasil Novartis Tempo inteiro

    Summary Medical leader for pipeline products. Gather healthcare system and stakeholders’ insights, develop and lead the execution of medical plan during the early launch timeframe for products/indication/ therapeutic area under responsibility. About the Role Key responsibilities:Ensure medical enquiries are responded to in a high quality, timely...


  • Santo Amaro, Brasil Healthcare Businesswomen’s Association Tempo inteiro

    Job Description Summary Medical leader for pipeline products. Gather healthcare system and stakeholders’ insights, develop and lead the execution of medical plan during the early launch timeframe for products/indication/therapeutic area under responsibility. Job Description Key responsibilities: Ensure medical enquiries are responded to in a high...


  • Santo Amaro, Brasil Novartis Farmacéutica Tempo inteiro

    Medical leader for pipeline products. Gather healthcare system and stakeholders’ insights, develop and lead the execution of medical plan during the early launch timeframe for products/indication/ therapeutic area under responsibility. About the RoleKey responsibilities: Ensure medical enquiries are responded to in a high quality, timely manner, and in...


  • Santo Amaro, Brasil Novartis Tempo inteiro

    Summary Medical leader for pipeline products. Gather healthcare system and stakeholders’ insights, develop and lead the execution of medical plan during the early launch timeframe for products/indication/ therapeutic area under responsibility.About the Role Key responsibilities: Ensure medical enquiries are responded to in a high quality, timely manner,...


  • Espírito Santo, Brasil buscojobs Brasil Tempo inteiro

    Specialism: IFS - Internal Firm Services - OtherJob Description & Summary:At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.As a...


  • Espírito Santo, Brasil buscojobs Brasil Tempo inteiro

    Specialism: IFS - Internal Firm Services - OtherJob Description & Summary:At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively.As a...

  • Accounting Analyst

    1 semana atrás


    Espírito Santo, Brasil buscojobs Brasil Tempo inteiro

    Welcoming, collaborative and having the opportunity to make an impact - is how our employees describe working here. Galileo is a financial technology company that provides innovative and revolutionary software products and services that power some of the world's largest Fintechs. We are the only payments innovator that applies tech and engineering...


  • Espírito Santo, Brasil buscojobs Brasil Tempo inteiro

    Specialism: IFS - Internal Firm Services - Other Job Description & Summary: At PwC, our people in risk and compliance focus on maintaining regulatory compliance and managing risks for clients, providing advice and solutions. They help organisations navigate complex regulatory landscapes and enhance their internal controls to mitigate risks effectively. As...

  • Accounting Analyst

    1 semana atrás


    Espírito Santo, Brasil buscojobs Brasil Tempo inteiro

    Welcoming, collaborative and having the opportunity to make an impact - is how our employees describe working here. Galileo is a financial technology company that provides innovative and revolutionary software products and services that power some of the world's largest Fintechs. We are the only payments innovator that applies tech and engineering...