Director leading compliance strategies at Walmart, enhancing operational integrity through tech collaboration and team leadership. Fostering partnerships to uphold ethical standards across the organization.
About the role
- Senior Regulatory Affairs Analyst at Johnson & Johnson, responsible for ensuring compliance and regulatory strategy in São Paulo. Involves preparation and submission of regulatory dossiers and compliance assurance.
Responsibilities
- Develop strategic analyses of business information from a regulatory perspective;
- Prepare and submit regulatory dossiers (New Products, Renewals, Line Extensions, and Variations);
- Ensure robustness in responses to regulatory requests;
- Conduct regulatory assessments of new business opportunities in collaboration with the New Business team;
- Maintain ongoing interactions with regional regulatory team members, Medical Affairs, Access, and Marketing;
- Participate in product launch teams;
- Monitor the company's regulatory submissions and approvals;
- Review promotional materials for the therapeutic area;
- Responsible for regulatory and competitive intelligence in the assigned therapeutic area;
- Attend meetings with external entities and internal meetings with different departments, contributing and sharing expertise;
- Interact with the Health Authority in meetings or via email;
- Monitor publication of new legislation, evaluate impacts, risks and opportunities, and develop a robust implementation plan;
- Ensure compliance with regulations and interpretations issued by the regulatory agency;
Requirements
- Bachelor's degree in Pharmacy, Biology, Biochemistry, Microbiology, Chemistry, or related fields;
- Solid professional experience in regulatory affairs, preferably with product registrations and pipeline management;
- Strong knowledge and experience with Pharmaceutical Industry regulations;
- Proficiency in Microsoft Office;
- Strong problem-solving skills;
- Advanced English (Spanish desirable);
Benefits
- Health benefits
- Hybrid work
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Manager, Field Compliance supporting US Psychiatry compliance program at Lundbeck. Driving and implementing all elements of Lundbeck US Compliance Program along with field - based teams.
Risk & Compliance Lead overseeing compliance management and statutory requirements at JLL. Leading audits and collaborating with cross - functional teams to mitigate legal risks and ensure compliance.
Coordinator for regulatory review assisting with product registration and compliance at e.l.f. Beauty, a leader in clean and cruelty - free cosmetics. Collaboration with cross - functional teams for global product launches.
Junior Compliance Manager supporting the development of a compliance management system at an international financial services company based in Cologne, focusing on digital processes and modern governance tools.
Senior Safety & PV Operations Specialist providing support to Safety and Pharmacovigilance. Identifying and maintaining worldwide regulatory requirements and serving as a subject matter expert in pharmacovigilance.
Quality and Regulatory Affairs Manager developing and supporting quality management systems for medical devices. Engaging in regulatory processes and facilitating innovation in healthcare.
Regulatory Affairs Analyst for Grupo GSH, overseeing compliance with health regulations and documentation processes. Supporting various internal teams and liaising with regulatory bodies.
Pensions Risk and Compliance Manager responsible for ensuring compliance in pension operations at TfL. Handling regulatory and legislative compliance while managing operational risks and quality issues.
Scientific and Regulatory Affairs Manager leading compliance and safety strategies for sustainable packaging at Mars. Collaborating across functions to drive food contact material safety initiatives.