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**Position Summary**
Johnson & Johnson Consumer Health is recruiting for a REGULATORY AFFAIRS SR. ANALYST, located in São Paulo (BR) or São José dos Campos (BR).
As a Regulatory Affairs Sr. Analyst, you will be the local regulatory responsible for Self-Care franchise for Brazil, which includes brands like Tylenol®, Nicorette®, Mylanta® and Benalet®.
You will hold a very strategic position connecting with regional RA and a multifunctional team (Marketing, R&D, Supply Chain, Quality Assurance and others) to support, implement and deploy the Brazilian regulatory strategy for Innovation pipeline and Life Cycle projects.
You will also have a meaningful role in igniting the potential for ground-breaking innovation, by bringing insights, innovative, digital, ambitious and science-based approach for these brands.
As we are hardworking on challenge the current state and bring improvements, we will work together on opportunities to pave the way to evolve the regulatory environment and set new market tendencies.
Do you want to make difference, transform lives through beloved brands?
We can do it together!
Bring your best and innovative ideas to build distinguished regulatory strategies that will lead us to excel in an evolving regulatory landscape and set us as key business partners!
**Key Responsibilities**
- Work with different areas as strategic partner, by being a point of connection or even the leader and establishing a positive relationship within local and regional cross-functional team to shape internal and external environment to deliver Self Care pipeline
- Provide innovative ways to develop and drive implementation of Innovation and Base Business portfolio projects.
Ensure business continuity by supporting and carrying out accurate regulatory strategy
- Map and bring insights of improvement on our internal projects' execution
- Bring through consumer focus an agile mentality to unlock regulatory path according to business strategy, working as an enabler
- Being responsible for define and share submissions requirements and provide significant inputs on preparation of dossiers for submission to ANVISA
- Review submission documents to ensure that they are fit for purpose, evaluating labeling statements as appropriate and supporting the responses to HA questions in line with product/franchise strategy
- Act as primary contact within Self Care regulatory Brazil team
**Qualifications**
- _Education: Bachelor's degree or Master's degree in a science related field, with shown experience in pharmaceutical industry in Brazilian Regulatory affairs environment_
- _Proven understanding in Pharma regulations, guidelines, policies, etc.
for new, similar, specific drugs and also dietary supplements (desirable) categories_
- _Strong knowledge regarding ANVISA's structure, ways of working and tendencies_
- _Solid understanding of the product development process and post market changes_
- _Shown ability to interpret and understand business context and regulations in the scientific and commercial environment_
- _Outstanding connection and teamwork skills with ability to work and communication with different partners like Marketing, R&D, regional regulatory, supply chain and QA._
- _Language: Advanced English (required) Advanced Spanish (desirable)_
- _Digital skills are desirable _
- _CTD expertise is a plus_
**Primary Location**
Brazil-São Paulo-São Paulo
- **Other Locations**
Latin America-Brazil-São Paulo-São José dos Campos
**Organization**
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda.
(7600)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206062003W