Analista de Conformidade Sr

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**Position Summary**

Johnson & Johnson Consumer Health is recruiting for a Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) Specialist (**Fixed-term position - 24 months**), located in São Jose dos Campos (BR), reporting to Associate Director/Director, Regulatory Affairs U.S. OTC

**Key Responsibilities**
- This position will work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval. Execute CMC regulatory strategies with internal research and development, and other technical/scientific colleagues. Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings. This position provides direction regarding the regulatory requirements of McNeil's new and marketed products, as well as helping support the implementation of long term companywide regulatory strategies and operating principles/practices

**Qualifications**
- Education: A minimum of a bachelor’s degree in relevant health-related scientific discipline or an advanced degree in a related field is preferred
- A minimum of 2 years of experience authoring and compiling all parts of Module 3 CMC sections is required. A minimum of 2 years of pharmaceutical industry experience is required. Previous experience with global products (small molecule/NCE) is preferred.
- Language: Advanced English (required) Intermediate/Advanced Spanish (required)
- Knowledge/familiarity with Brazil and Mexico regulatory registration of drugs is required.
- Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment is required
- Work independently, manage several complex projects/issues in parallel, and effectively influence others in a cross-functional team setting with a solution-oriented and enterprise mindset.
- Experience interacting with health authorities is preferred
- Experience interacting with relevant trade associations or serving on trade association committees is preferred

**Primary Location**
Brazil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154
**Organization**
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206029101W