Regulatory Affairs Specialist

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

Our 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 medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

**We are searching for the best talent for We are searching for the best talent for Regulatory Affairs Specialist - São Paulo-SP**
- Under supervision, it is responsible for regulatory activities to support and grow the business in line with the company goals. This includes:
**Principal Responsibilities**:
**Regulatory Policy & Intelligence**:

- Shapes & influences the regulatory environment including working on or commenting on Health Authority new regulations, future regulations and new approaches for current regulations through participation in discussion groups Trade Association as a team member.
- Participates in the Trade Associations working groups and meetings.
- Work with Regional Office within J&J and CMCs, as appropriate for new and/or updated Regulations that may impact.

**Regulatory Strategy**
- Prepare and submit regulatory submissions (e.g. ANVISA database corrections, DCB request, labeling notifications, leaflet notifications, variations, registration submissions amendments etc) and HA queries timely;
- Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems) and regulatory systems;
- Regulatory Intelligence review for the products;
- Review promotional materials;
- Contributes with the regulatory strategy of new business projects for Brazil, including Marketing Authorization Holder Transfer and other Special Projects;
- Dossier evaluation for pending requirements identification using the gap analysis spreadsheet and calls with Regional Office to expedite pending information/documentation receipt; Interacts and aligns with internal/local business partners (e.g. Medical Affairs, Marketing, Supply, CMC-RA, etc) to contribute with registered product strategy, local registration and other regular activities;
- Participation in product delisting process informing the regulatory status and impact assessment;
- Close contact with Commercial Quality, Laboratory, Supply and Packaging Development to keep all teams updated about submissions and aligned with product stock-outs, recalls, out of specifications and other quality issues;

**Post Approval Commitments**
- Management of post-approval commitments are acted upon in case they are accepted by ANVISA.

**Qualifications / Requirements**:

- Minimum: degree in Pharmacy and Biochemistry.
- Generally requires (6-8) years related experience.
- Hands
- on experience in pharmaceutical product registration.
- Understanding of commercial business.
- Demonstrated ability to handle multiple projects.
- Working knowledge of local regulations and guidelines related to drug development and registration.
- Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
- Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
- Proficient use of technology including MS office programs and Internet resources.
- Position located in São Paulo-SP - Hybrid model, 3 times a week in the office.
- Travel: frequent to Brasília (ANVISA) and infrequent to Global Offices/other countries.