Regulatorry Affairs Manager

3 meses atrás


São Paulo SP, Brasil Johnson & Johnson Tempo inteiro

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

We are seeking an experienced and dynamic Regulatory Affairs Manager to join our team at J&J Innovative Medicine.

Key Responsibilities:

- Leadership:

- Lead and mentor a team of regulatory affairs professionals, providing guidance, performance management, and career development opportunities.
- Foster a culture of collaboration, innovation, and regulatory excellence within the team.
- Regulatory Strategy:

- Develop and implement regulatory strategies to support new product introductions, including pre-submission meetings, regulatory submissions, and interactions with regulatory authorities.
- Provide strategic guidance on regulatory requirements to cross-functional teams during development projects and product lifecycle management.
- Regulatory Submissions:

- Prepare and submit high-quality regulatory dossiers for new product registrations (NDA/BLA) in accordance with regional and international guidelines.
- Manage the preparation, review, and submission of post-registration variations, ensuring compliance with legal and regulatory requirements.
- Post-Registration Activities:

- Oversee post-registration activities such as maintenance of marketing authorizations, labeling updates, and amendments.
- Ensure timely submissions for variations, renewals, and other regulatory processes.
- Labeling and Artwork:

- Ensure labeling, packaging, and artwork for regulatory compliance.
- Maintain up-to-date knowledge of labeling regulations and guidelines.
- Change Control:

- Establish and manage change control assessments to ensure all regulatory changes are documented, assessed, and implemented appropriately.
- Collaborate with cross-functional teams to assess the impact of changes on regulatory submissions and approvals.
- Compliance and Process Improvement:

- Ensure compliance with all relevant regulations, guidelines, and internal SOPs.
- Identify opportunities for process improvements and implement best practices in regulatory affairs.
- Take part of Regulatory Governances including Commercial Quality, Regional Regulatory and global regulatory.
- Implement innovative process and take part of local, regional e global trade unions discussion.

**Qualifications**:

- Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced degree preferred including MBA or MD certification.
- Robust experience in the pharmaceutical industry with a focus on regulatory affairs.
- Solid leadership experience, managing and developing high-performing teams.
- Extensive knowledge of regulatory requirements and processes for new product introductions, post-registration variations, labeling, artwork, and change control.
- Proven track record in preparing and submitting regulatory dossiers and managing interactions with regulatory authorities.
- Strong understanding of local and international regulatory guidelines (e.g., FDA, EMA, ICH, PIC/s, WHO).
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Challenging processes, procedures and decisions is expected.
- Result-oriented with strong organizational and project management skills.
- Advanced English is mandatory.
- Spanish is preferred.



  • São Paulo, Brasil JM Huber Corporation Tempo inteiro

    Summary The Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (HAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. The RA Manager provides expertise for regulatory affairs projects supporting business maintenance and / or growth and right to...


  • São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiro

    Job title:Regulatory Affairs Team Manager - Vaga Exclusiva Para Pessoas com Deficiencia (PcD)Location:São Paulo/SPAbout the jobRegulatory Affairs team in Brazil is part of a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with Health Authorities...


  • São Paulo, São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiro

    OverviewCatho Online Ltda. is seeking a skilled Regulatory Affairs Team Manager to join our team in São Paulo, Brazil.This is an exciting opportunity for a seasoned professional to lead our regulatory affairs team and contribute to the growth and success of our organization.


  • São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiro

    Job title: Regulatory Affairs Team Manager - Vaga Exclusiva Para Pessoas com Deficiencia (PcD) Location: São Paulo/SP About the jobRegulatory Affairs team in Brazil is part of a single digitally savvy and agile regulatory community effectively partnering with our diverse business units and platforms by building constructive relationships with Health...


  • Sao Paulo, Brasil Unilever Tempo inteiro

    **Unilever is currently hiring for a Regulatory Affairs Manager based in São Paulo.** **Unilever** is the place where you can bring your purpose to life with the work that you do - creating a better business and a better world. We are looking for talents that would like to join this exciting journey with us. Our **R&D Brazil Beauty & Wellbeing** team is...


  • São Paulo, São Paulo, Brasil Kenvue Brands Llc Tempo inteiro

    We are seeking an experienced Medical Affairs Project Manager to join our team at Kenvue Brands LLC. This role will be based in São Paulo and will provide project management and operational business support to the North America Medical Affairs function, North America Public Health (NAPH), and global Medical, Clinical, and Safety Sciences (MCSS)...


  • São Paulo, SP, Brasil Kaspersky Tempo inteiro

    Kaspersky has been protecting individuals and corporate clients all over the world from cyber threats for 26 years . We have 400 million unique users, 270.000 corporate clients, 517 products, 1.100 technological patents and 34 offices around the world. Today our team has more than 4.000 top level experts, all of them regular people with their own...


  • São Paulo, Brasil Amazon Tempo inteiro

    Work hard, have fun, and make history with Amazon Public Policy. The Manager, Public Policy, will have the responsibility to help develop and execute government affairs advocacy objectives and political priorities for Amazon on federal policy issues in Brazil.The Manager will create and execute a federal government affairs strategy to set the agenda with the...


  • São Paulo, Brasil Quality Compliance Tempo inteiro

    Regulatory Affairs Manager Quality Compliance Quality Compliance is a company of excellence in Life Sciences and one of the largest employers in the Brazilian pharmaceutical sector. We offer opportunities for you to join and grow in your career, which is we are always looking for new talents to join our team and our clientes for contribute to improving the...

  • Service Manager

    2 meses atrás


    São Paulo, SP, Brasil MaxSearch Tempo inteiro

    The Service Manager is responsible for managing the relevant Service department by monitoring costs, revenues and employees This position ensures day-to-day service and/or support delivery. **Responsabilidades e atribuições** - Steer resources and operational service and support business; - Provide forecasts of costs, revenues and employees utilization; -...


  • São Paulo, Brasil Kaspersky Tempo inteiro

    Kaspersky has been protecting individuals and corporate clients all over the world from cyber threats for 26 years.We have 400 million unique users, 270.000 corporate clients, 517 products, 1.100 technological patents and 34 offices around the world.Today our team has more than 4.000 top level experts, all of them regular people with their own talents and...


  • São Paulo, Brasil Kaspersky Tempo inteiro

    Kaspersky has been protecting individuals and corporate clients all over the world from cyber threats for 26 years.We have 400 million unique users, 270.000 corporate clients, 517 products, 1.100 technological patents and 34 offices around the world.Today our team has more than 4.000 top level experts, all of them regular people with their own talents and...


  • São Paulo, Brasil Kaspersky Tempo inteiro

    Kaspersky has been protecting individuals and corporate clients all over the world from cyber threats for 26 years.We have 400 million unique users, 270.000 corporate clients, 517 products, 1.100 technological patents and 34 offices around the world.Today our team has more than 4.000 top level experts, all of them regular people with their own talents and...

  • Manager, Public Policy

    3 semanas atrás


    São Paulo, Brasil buscojobs Brasil Tempo inteiro

    This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.DESCRIPTION :Work hard, have fun, and make history with Amazon Public Policy. The Manager, Public Policy, will have the responsibility to help develop and execute government...

  • Regulatory Affairs Team Lead

    4 semanas atrás


    São Paulo, São Paulo, Brasil Catho Online Ltda. - BR - Chefe Tempo inteiro

    As a Regulatory Affairs Team Manager at Catho Online Ltda. in São Paulo, Brazil, you will lead the regulatory affairs team and drive their development journey in line with global strategy.About the RoleYou will collaborate with the affiliate head to achieve regulatory objectives, oversee team performance, and foster strong relationships within global...

  • Customer Affairs Manager

    6 meses atrás


    Sao Paulo, Brasil The Emirates Group Tempo inteiro

    Job Purpose: Manage a team of Customer Affairs representatives and ensure that service failures are fully investigated and service recovery processes are implemented in a timely and cost effective manner ensuring that capital and service recovery expenses are within budget. Win back customer loyalty from those who have experienced dissatisfaction with...

  • Public Affairs Associate

    7 meses atrás


    São Paulo, Brasil Lalamove Tempo inteiro

    Founded in Hong Kong in 2013, Lalamove is an on-demand delivery platform born with a mission to empower communities by making delivery fast, simple, and affordable. At the click of a button, individuals, small businesses, and corporations can access a wide fleet of delivery vehicles operated by professional driver partners.Powered by technology, we...


  • são paulo, Brasil Kaspersky Tempo inteiro

    Kaspersky has been protecting individuals and corporate clients all over the world from cyber threats for 26 years . We have 400 million unique users, 270.000 corporate clients, 517 products, 1.100 technological patents and 34 offices around the world. Today our team has more than 4.000 top level experts, all of them regular people with their own talents...

  • Business Development Manager

    2 semanas atrás


    São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiro

    Kronos Alimentos, a subsidiary of Mitsui & Co. Ltd., is seeking an experienced Business Development Manager to lead its expansion efforts in Contracts and Regulatory Affairs.The ideal candidate will have a strong background in business development, with expertise in contract management and regulatory compliance. They will be responsible for identifying new...

  • Grouper Medical Manager

    4 meses atrás


    São Paulo, SP, Brasil Novo Nordisk Tempo inteiro

    Grouper Medical Manager - Obesity **Category**:Medical Affairs**Location**:São Paulo, São Paulo, BR- **The position** - This professional will be responsible for leading Obesity its pipeline, guiding the medical managers so they are able to deliver scientific activities across all focus areas, and also for leading the Strategic Operations service, being...