Manager, RA Submissions

4 semanas atrás

São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro

Overview

Join to apply for the Manager, RA Submissions role at Johnson & Johnson Innovative Medicine .

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Learn more at

This hybrid work position will be located in Sao Paulo, Brazil.

Job Description

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

Responsibilities
  • Coordinate the preparation and maintenance of global regulatory submissions and filings in line with regulatory strategy.
  • Create and manage dossier plans/submission packages, seeking input from regulatory therapeutic areas, functional area representatives, and key partners, while providing guidance to project team members.
  • Contribute to decisions that have an impact on the quality and timeliness of Health Authority submissions.
  • Make decisions on submission operational strategies for an optimal project management approach within process/timeline/resource constraints.
  • Lead cross-functional submission team meetings to coordinate the preparation and maintenance of regulatory submissions and filings.
  • Provide leadership for monitoring and efficiency of the submission process, initiating changes within the scope of decision-making authority to optimize efficiencies and ensure quality.
  • Cultivate effective relationships, maintaining open communication with key partners to ensure priority challenges, resource issues, and deviations from the plan are identified and resolved.
  • Demonstrate ability to lead the development of strategic initiatives, department practices, process improvements, and training materials.
  • May be responsible for the performance and development of direct reports.
Education and Experience
  • University/bachelor’s degree and 6 years of related professional experience.
  • Masters/PharmD/PhD in combination with 4 years of relevant/related professional experience.
Required
  • In-depth understanding of the drug development process across regional and functional areas.
  • Effective interpersonal, teamwork, and communication skills.
  • Ability to work or lead in a matrix environment and influence stakeholders, strong collaboration skills.
  • Fluency in English; other languages may be required depending on assignment.
  • Knowledge of Regulatory Information Systems, planning, and publishing tools.
  • Knowledge and skills to build productive relationships across the organization and with external stakeholders.
  • In-depth knowledge of project and submission management.
  • Demonstrated proactivity, problem solving, troubleshooting, and adaptability.
  • Proficiency in submission related Health Authority and Industry regulations and guidelines as relevant.
Preferred
  • Minimum 6 years progressive business experience within Regulatory Affairs or interfacing business areas.
  • Minimum 1-3 years of experience within Global Regulatory Affairs with Masters/PharmD/PhD degree.
Other
  • May require up to 5% travel, domestic and international.
Seniority level
  • Not Applicable
Employment type
  • Full-time
Job function
  • Other
Industries
  • Pharmaceutical Manufacturing
#J-18808-Ljbffr

  • Manager, RA Submissions

    3 semanas atrás

    São Paulo, Brasil Johnson & Johnson Tempo inteiro

    Overview At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Manager, RA Submissions

    1 semana atrás

    São Paulo, São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro R$13.200 - R$39.600 por ano

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Associate Director, Regulatory Submissions

    Há 20 horas

    Sao Paulo, Brasil Medpace, Inc. Tempo inteiro

    Job Summary: As our activities in Latin America are developing rapidly, we are currently looking for a full-time, office-based, Associate Director, Regulatory Submissions, based in Sao Paulo, Brazil to join our Site Activation & Maintenance team. This position will allow you to join a key team in the success of the company. If you want to develop your career...

  • Senior Regulatory Affairs Associate

    Há 3 dias

    São Paulo, SP, Brasil Parexel Tempo inteiro

    As a Senior Regulatory Affairs Associate you will have the opportunity to work within Regulatory Authority Submissions related to Clinical Trials, supporting many projects in Brazil. Previous experience submitting clinical trials to ANVISA is required. Responsible for quality deliverables at the country level; follows project requirements and applicable...

  • Qa & Ra Specialist

    1 semana atrás

    São Paulo, Brasil Selectchemie AG Tempo inteiro

    Work place: Sao Paulo, Brazil QA & RA Specialist (100 % workload) About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive...

  • Qa & Ra Specialist

    1 semana atrás

    São Paulo, Brasil BR - W JB Tempo inteiro

    Work place: Sao Paulo, Brazil QA & RA Specialist (100 % workload) About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive...

  • Qa & Ra Specialist

    1 semana atrás

    São Paulo, Brasil Selectchemie AG Tempo inteiro

    Work place: Sao Paulo, Brazil QA & RA Specialist (100 % workload)About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive...

  • Qa & Ra Specialist

    1 semana atrás

    São Paulo, Brasil Selectchemie AG Tempo inteiro

    Work place: Sao Paulo, Brazil QA & RA Specialist (100 % workload) About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive...

  • Qa & Ra Specialist

    1 semana atrás

    São Paulo, Brasil Selectchemie AG Tempo inteiro

    Work place: Sao Paulo, Brazil QA & RA Specialist (100 % workload)About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive...

  • Qa & Ra Specialist

    1 semana atrás

    São Paulo, Brasil Selectchemie AG Tempo inteiro

    Work place: Sao Paulo, Brazil QA & RA Specialist (100 % workload) About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full service provider we create added value by offering comprehensive...