Senior Regulatory Affairs Specialist

Há 2 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$90.000 - R$120.000

Regulatory Strategy Senior Manager Job Description

Job Summary:

The International Regulatory Strategy Senior Manager will assist in the start-up and regulatory submission for geographic expansion in Latin American markets. This is a hybrid role based in our Sao Paulo office.

Key Responsibilities:

  • Participates in the development and implementation of regulatory strategy for Brazil and Latin America.
  • Assists Development teams and regulatory management in developing strategies that are Brazil and LATAM appropriate.
  • Supports clinical teams with regulatory support to study start-ups and maintenance activities by leading all associated regulatory activities.
  • Provides assessments of regulatory requirements for Latin American expansion.
  • Ensures compliance on regulatory requirements and regulatory files.
  • Manages interactions with local regulatory agencies and attends meetings with HA when required.
  • Monitors and assesses the impact of new regulations and guidance documents.
  • Supports promotional and non-promotional material review.
  • Addresses complex issues and problems providing innovative solutions and guidance to the team.
  • Prepares presentations to global regulatory and cross-functional teams.
Required Skills and Qualifications:
  • Bachelor's degree in Pharmacy.
  • Strong experience of relevant pharmaceutical or biotech industry experience within regulatory affairs in Brazil.
  • High-level knowledge of medicines regulations.
  • Strong CMC knowledge.
  • Experience providing strategic regulatory inputs for the development of innovative medicinal products.
  • Proven track record of supporting regulatory submissions in Brazil.
  • Experience in directly working with national regulatory agencies and leading the preparation of Health Authorities meetings.
  • Ability to negotiate and concisely express clear positions to stakeholders at all levels.
  • Solid project management skills.
  • Self-motivated, with the ability to work independently.
  • Excellent written and verbal communication skills.
  • Fluent in English to communicate in meetings and present to different levels in the organization, local and international.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

  • Governmental & Regulatory Affairs Specialist

    Há 4 dias

    São Paulo, São Paulo, Brasil UBS Tempo inteiro

    Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Job Reference # BRJob TypeFull TimeYour roleAre you curious, have attention to detail and the ability to...

  • Regulatory Affairs Specialist

    Há 3 dias

    São Paulo, São Paulo, Brasil beBeeRegulatoryAffairs Tempo inteiro R$900.000 - R$1.200.000

    Regulatory Affairs ProfessionalThis role seeks a detail-oriented individual with excellent communication skills, capable of navigating complex regulatory environments. You will collaborate with a dynamic team focused on delivering key regulatory insights.Main Responsibilities:Build and maintain relationships between UBS and local regulators to ensure...

  • Governmental & Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil UBS Tempo inteiro

    Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Job Reference #321151BRJob TypeFull TimeYour roleAre you curious, have attention to detail and the ability...

  • Regulatory Affairs Specialist

    Há 4 dias

    São Paulo, São Paulo, Brasil beBeeregulatory Tempo inteiro R$64.000 - R$97.000

    Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to support regional Chemistry, Manufacturing and Control (CMC) strategy, the preparation of documentation, and the execution of regional post-approval submissions and new product registrations.Main Responsibilities:Assess regulatory change control by identifying requirements...

  • Regulatory Affairs Senior Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Johnson & Johnson Family of Companies Tempo inteiro

    **Regulatory Affairs Senior Specialist**:At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion...

  • Regulatory Affairs Specialist

    Há 2 dias

    São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro

    **Job Function**:Regulatory Affairs Group**Job Sub Function**:Regulatory Affairs**Job Category**:Professional**All Job Posting Locations**:São Paulo, BrazilOur 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...

  • Expert Regulatory Affairs Specialist

    Há 2 dias

    São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$100.000 - R$150.000

    Regulatory Affairs SpecialistOur team is seeking a highly skilled Regulatory Affairs Specialist to join our organization. As a key member of our team, you will be responsible for leading regulatory activities and providing expert input on formulation and claims assessments.Key Responsibilities:Lead and conduct regulatory assessments for Brazil B&W, focusing...

  • Regulatory Affairs and Public Policy Specialist

    Há 3 dias

    São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$90.000 - R$120.000

    Job Opportunity: Regulatory Affairs and Public Policy SpecialistEntain is a leading global sports betting and gaming company operating in the online and retail sectors. With a presence across five continents and licenses in over 30 countries, we have a combined history of more than 250 years.As part of our Global Regulatory Affairs team, you will play a key...

  • Senior Regulatory Affairs Specialist

    Há 3 dias

    São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$180.000 - R$250.000

    We're looking for a seasoned professional to oversee our Regulatory Affairs Department. This individual will ensure compliance with local regulations and quality system requirements, fostering an environment of operational excellence through regulatory expertise and effective team management.Main Responsibilities:Supervise the Regulatory Affairs Department...

  • Regulatory Affairs Specialist

    4 semanas atrás

    São Paulo, São Paulo, Brasil Envu Tempo inteiro

    We're HiringRegulatory Affairs SpecialistAt Envu, we partner with our customers to design world-class, forward-thinking innovations that protect and enhance the health of environments around the world. We offer dedicated services in: Professional Pest Management, Forestry, Ornamentals, Golf, Industrial Vegetation Management, Lawn & Landscape, Mosquito...