Senior Analyst in governance of accesses ensuring critical access requests at Riachuelo. Responsible for data governance and risk control strategies in São Paulo.
About the role
- Director of Regulatory Vault Operations overseeing GSK’s regulatory systems and leading strategic initiatives. Responsible for compliance and efficiency in regulatory submissions across a global landscape.
Responsibilities
- Set the strategic direction and lead the delivery of Regulatory Vault Continuous Improvement.
- Oversee and optimize the technology infrastructure and digital platforms supporting regulatory and development operations.
- Partner with Tech and R&D Quality teams to ensure full GxP validation and prepare for regular inspections.
- Develop and execute strategies that integrate system operations, reporting and analytics, and support services.
- Work closely with cross-functional teams to ensure cohesive efforts in system operations and support services.
- Identify and implement innovative solutions and best practices to enhance system operations and reporting.
- Ensure all systems, reporting, and support services adhere to regulatory guidelines and standards.
- Lead, mentor, and develop a high-performing team to support GSK’s regulatory and development objectives.
Requirements
- An advanced degree in a relevant discipline such as Regulatory Affairs, Pharmaceutical Sciences, Biotechnology, Business or a related field.
- Expert level knowledge of Veeva Regulatory Vault and the Vault platform including configuration and customization capabilities.
- Strong experience working within the pharmaceutical, biotechnology or life sciences industry, focusing on regulatory affairs, clinical development or regulatory operations.
- Strong experience with service management around enterprise systems, including change and release management and end user support.
- Strong experience with GxP validation, inspection readiness, and Quality Management Systems including management and resolution of deviations, CAPAs, and findings.
- Deep knowledge of regulatory and development systems, including platforms supporting submissions, tracking and regulatory operations (e.g. RIM, eCTD and related environments).
- Proven expertise in data, reporting and analytics, using insights to support decision-making and operational performance.
- Demonstrated experience leading senior, cross-functional teams and delivering strategic initiatives in complex, matrixed organisations.
- A solid understanding of global regulatory requirements and compliance, with the ability to manage risk and ensure data integrity across systems and processes.
- Experience operating in global environments, working across multiple regulatory regions and health authorities.
Benefits
- Private healthcare
- Additional paid days off
- Life insurance
- Private pension plan
- Fully paid parental leave & care of family member leave
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Compliance Analyst ensuring adherence to legal and company standards at Copa Energia, monitoring training programs and supporting data protection compliance.
Regulatory Compliance Specialist ensuring compliance with payment card regulations. Collaborating with cross - functional teams to develop and maintain compliant programs in a fintech environment.
Head of Compliance & AMLCO leading compliance and AML/CTF function for Cyprus - regulated Electronic Money Institution. Serving as the primary point of contact with the Central Bank of Cyprus.
GRC Analyst supporting ISO27001 certification preparation at Asiera. Collaborating with technical teams for documentation and compliance.
Cyber GRC Senior Consultant supporting companies in enhancing cybersecurity and compliance. Collaborating with client teams to implement cybersecurity policies and conduct risk assessments.
Internal Controls & Compliance Supervisor managing compliance with SOX and internal controls at Solventum, a healthcare company enhancing solutions for healthcare professionals.
Regulatory Affairs Specialist ensuring compliance and strategic oversight at Multiverse. Drafting regulatory submissions and coordinating oversight processes within a hybrid work environment.
Director of Deposit Compliance responsible for leading compliance efforts for deposit products at Northwest Bank. Ensuring adherence to regulations and managing risk assessment processes for effective compliance operations.
Chargé de la Qualité et Conformité en alternance pour Economie d’Energie. Soutenir la conformité et le contrôle interne tout en participant à la transition énergétique en France.