Regulatory Affairs Specialist

2 semanas atrás

Sao Paulo, Brasil Johnson & Johnson Tempo inteiro

We are searching for the best talent for **Regulatory Affrairs Specialist** to be in São Paulo. In this role the main responsabilities are:

- Ensure registration pipeline/changes and renewals program submission is done in timely manner
- Participate in teams to execute regulatory strategic plans with some guidance.
- Prepare and submit proper regulatory documents and technical files to MoH with mínimal supervision.
- Provide assistance with establishment registration licenses.
- Contribute to introduce new /modified products/ line extension & others.
- Manage and track regulatory projects/requests to ensure alignment with business goals and timely responses
- Prepare alert communications according to registration process progress and findings during this.
- Supports regional team on product submissions schedules, prioritization, and pipeline management.
- Interacts with other JJ stakeholders, government agencies in a professional, decisive, & articulate manner.
- Act as liaison for assigned franchises to support business plans and regulatory needs.
- Request and follow-up documentation from OCs to prepare registration dossiers
- Review and analyze market licenses and labeling to set up product codes status
- Ensure that Regulatory and Labeling Databases are well updated as per approvals received
- May identify and communicate new regulatory/legal requirements.
- Support Commercial, bids and functional areas consultations to clarify regulatory questions
- Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies.
- Adhere to company and regulatory bodies’ policies and procedures regarding product introductions, changes and labeling.

**Qualifications**:
**Education**:

- Bachelor’s Degree in Engineering, Pharmacy, or other life science;
- Desirable: Related experience and/or training or equivalent combination of education and experience
- Advanced Skills in English;
- Fluent in Portuguese.
- Spanish - will be considered an asset

**Experience**:

- Must have 1-2 years’ experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Brazilian Health Authorities and a successful track record.
- Desirable experience in Medical Devices or Pharma background.

Competencies:

- Knowledge of Local & International Regulation and Processes;
- Analytical capability and investigative skills;
- Self-motivated and committed to a team approach;
- Communicates clearly and effectively;
- Prioritizes work to meet deadlines;
- Planning and Organizing skills;
- Understands the importance of the adherence to compliance;
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive;
- Project Management skills and ability to manage complex data with excel spreadsheets are desirable.

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