Regulatory Operations Manager

Job Location

SAO PAULO GENERAL OFFICE

Job Description

We are looking to hire a Regulatory Operations Manager for our Personal Health Care (PHC) business, based in Sao Paulo, Brazil. This role involves supporting the regulatory affairs teams, particularly in the US and Latin America, by ensuring the accuracy and efficiency of regulatory operations. The ideal candidate will have a strong scientific background, preferably in pharmacy, medicine, chemistry, or biology, and experience with regulatory systems like Veeva RIM. Particular focus on content planning and publishing are core competencies for this role. The position requires at least three days per week in our Sao Paulo Brazil office to foster collaboration and team integration. This is an excellent opportunity for someone looking to grow within a diverse, vibrant, and supportive team environment at P&G.

As the Regulatory Operations Manager, you will:

• Collaborate with cross-functional US PHC team members, building team members’ understanding of documentation requirements for compliant eCTD-submissions.
• Work with Regulatory Affairs and submission team members to define metadata necessary to update Veeva RIM records.
• Work with Regulatory Affairs and submission team members to define dossier content for submissions in the United States.
• Content planning Management: Manage the process from creation to submission of dossiers to the FDA while ensuring document alignment, document status monitoring and enabling publishing.
• Drive the troubleshooting of systems (e.g., Veeva RIM, Content planning & publishing etc) and applications based on their technical proficiency.
• Provide document management support, as needed, to facilitate on-time delivery of electronic submission ready documents.
• Champion data verification and enable data literacy among users.
• Drive/lead process improvement, dossier management and data governance in both LATAM and North America.
• Understand the business processes and the needs of the end user and design packaged systems with proper impact analysis, custom programs, front-end applications, and integrations that adhere to best practices and meet user needs.
• Contribute to data-driven decision making by leading/driving the interpretation and analysis of data from various sources (reporting capabilities).

Job Qualifications

Education:

• Degree in Life Science (Pharmacy, Medicine, Chemistry, Biology) or previous regulatory/regulatory operations experience.
• Minimum 3 to 5 years’ experience in Regulatory Affairs or Regulatory Operations.
• Extensive experience in a highly regulated scientific environment, interacting with and interpreting various laws and regulations globally (Human Safety/R&D/Quality) preferably in the United States & Canada. Having Latin America experience would be a plus.

Job Schedule

Full time

Job Number

R000125440

Job Segmentation

Experienced Professionals (Job Segmentation)

Starting Pay / Salary Range: $85,000.00 - $115,000.00 / year