Regulatory Compliance Senior
hace 4 semanas
EY - GDS Consulting - Enterprise Risk (ER) - Regulatory Compliance - Senior
As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior, you will actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high-quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as the EY senior management team, and lead internal initiatives.
The opportunity
We’re looking for a Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offerings.
Your key responsibilities
- Actively contribute to the IT applications project management initiatives that include Validation activities as per GAMP Life Cycle approach.
- Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System, etc.
- Troubleshoot IT application-related issues and suggest recommendations for solutions in consultation with relevant functions.
- Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies are in line with Life Cycle Approach.
- Perform Software classification, IT risk assessment, and Mitigation strategies for IT applications.
- Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement.
- Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
- Create innovative insights for clients, adapt methods & practices to fit operational team needs & contribute to thought leadership documents.
- Demonstrate teamwork by working with cross-functional teams across service lines in completing the deliverables within the timelines.
- Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
- Review status updates and prepare management presentations.
- Actively contribute to improving operational efficiency on projects & internal initiatives.
- Demonstrate a detailed knowledge of market trends, competitor activities, EY products, and service lines.
- Contribute to performance feedback for staff.
- Foster teamwork and a positive learning culture.
- Understand and follow workplace policies and procedures.
- Train and mentor project resources.
- Cross-skill and cross-train the team members as per the business requirements.
Skills and attributes for success
- Prior experience of leading quality and compliance projects in Regulatory Compliance.
- Sound domain knowledge in the pharmaceutical industry in the areas of Quality Management System - Quality control, Quality assurance.
- Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems.
- Hands-on experience of preparing validation deliverables for software implementation projects.
- Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11.
- Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa, etc.
- Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC.
- Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System, etc. in Pharmaceutical organization.
- Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix, Data Migration strategy and report, etc.
- Demonstrated track record in project management, governance, and reporting.
- Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls, etc.
- Exposure to Data Integrity requirements and other applicable regulations.
- Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures.
- Prior experience of supporting Audits / Inspections.
To qualify for the role, you must have
- B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies.
- Good interpersonal skills.
- Good written, oral and presentation skills.
-
Regulatory and Compliance Counsel
hace 4 semanas
distrito federal, México World Business Lenders, LLC A tiempo completoAbout World Business Lenders ( World Business Lenders (WBL) provides general purpose short-term real estate collateralized commercial loans to a broad customer base comprised of small and medium sized businesses throughout the United States that lack access to traditional funding. WBL is a U.S.-based company with a 100% remote workforce. This is a remote...
-
distrito federal, México Moody's A tiempo completoLocation(s): Cda. San Isidro 44, Reforma Soc, Miguel Hidalgo, Mexico City, Mexico State, 11650 CDMX, MX Line Of Business: Compliance (COMPLIANCE) Job Category: Corporate Services Experience Level: Experienced Hire At Moody's, we unite the brightest minds to turn today’s risks into tomorrow’s opportunities. We do this by striving to create an...
-
distrito federal, México Moody's Investors Service A tiempo completoLocation(s): Cda. San Isidro 44, Reforma Soc, Miguel Hidalgo, Mexico City, Mexico State, 11650 CDMX, MX Line Of Business: Compliance(COMPLIANCE) Job Category: Corporate Services Experience Level: Experienced Hire At Moody's, we unite the brightest minds to turn today’s risks into tomorrow’s opportunities. We strive to create an inclusive...
-
distrito federal, México ICON A tiempo completoSenior Regulatory Affairs Specialist with Experience in Clinical Trials Site: Mexico City Office with Flex: 3 days at office and 2 days at home We are currently seeking a Senior Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Regulatory Affairs Specialist at ICON, you will play a pivotal role in ensuring regulatory...
-
distrito federal, México ICON A tiempo completoSenior Regulatory Affairs Specialist with Experience in Clinical Trials - Mexico City - Office with Flex ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical...
-
distrito federal, México ENGINEERINGUK A tiempo completoYou will need to login before you can apply for a job. Senior Regulatory Affairs Specialist with Experience in Clinical Trials Senior Regulatory Affairs Specialist with Experience in Clinical Trials - Mexico City - Office with FlexICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive...
-
distrito federal, México ICON plc A tiempo completoSenior Regulatory Affairs Specialist with Experience in Clinical Trials Site: Mexico City Office with Flex: 3 days at office and 2 days at home We are currently seeking a Senior Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Regulatory Affairs Specialist at ICON, you will play a pivotal role in ensuring regulatory...
-
Compliance Counsel
hace 2 meses
distrito federal, México WBL California, LLC A tiempo completoAbout World Business Lenders ( ) World Business Lenders (WBL) provides general purpose short-term real estate collateralized commercial loans to a broad customer base comprised of small and medium sized businesses throughout the United States that lack access to traditional funding. This is a Contract/Consultant position. Generally, working hours will be...
-
Regulatory Affairs Leader
hace 4 semanas
distrito federal, México Novartis Farmacéutica A tiempo completoEnsures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify...
-
distrito federal, México SimCorp A tiempo completoSenior Business Consultant in Regulatory Reporting Location: Manila Time Type: Full time Posted on: Yesterday End Date: November 30, 2024 (29 days left to apply) Who we are: For over 50 years, we have worked closely with investment and asset managers to become the world’s leading provider of integrated investment management solutions. We are 2,800+...
-
Senior Manager, Reporting and Analytics
hace 1 mes
distrito federal, México GSK A tiempo completoSite Name: Poznan Grunwaldzka, Mexico City Torre Mitikah, Mississauga Milverton DrivePosted Date: Oct 31 2024Senior Manager, Reporting and Analytics The Global Regulatory Operations Reporting Senior Manager at GlaxoSmithKline (GSK) is responsible for leading and managing the development, implementation, and maintenance of reporting services that support...
-
Senior Tax Analyst, Indirect Tax Compliance
hace 1 mes
distrito federal, México Amazon A tiempo completoSenior Tax Analyst, Indirect Tax Compliance Amazon's diverse business requires VAT filings in a number of jurisdictions globally. Amazon is seeking an energetic and enthusiastic VAT Compliance Tax Analyst to work in its International Indirect Tax Compliance team based in Mexico City, Mexico. The Amazon Tax Department is a fast-paced, team-focused, and...
-
LatAm Trade Compliance Analyst
hace 2 meses
distrito federal, México Levi Strauss & Co A tiempo completoJOB DESCRIPTION Company : We’re a company of people who like to forge our own path. We invented the blue jean in 1873, and we reinvented khaki pants in 1986. We pioneered labour and environmental guidelines in manufacturing. And we work to build sustainability into everything we do. Our brands stand for freedom and self-expression around the world. Where...
-
distrito federal, México HSBC A tiempo completoRole purpose This role within LAM Compliance Assurance (CA) is responsible for contributing to and implementing the ongoing strategic activities of the CA function for the businesses in LAM. CA is responsible for second line assurance activity over all compliance risk-related controls, whether operated within the First Line of Defense (1LOD) or Second Line...
-
Amazon | Principal Risk Manager, Transportation Risk
hace 2 semanas
distrito federal, México Amazon A tiempo completoDo you want to help Earth’s most customer-centric company design, implement and monitor risk mitigation strategies to improve the customer experience and protect Amazon’s brand?In this role, you will develop, manage, and execute Amazon’s transportation compliance audit strategy for the LATAM Last Mile business. You will collaborate with Risk and...
-
ERP Assurance Senior Consultant
hace 2 meses
distrito federal, México SENIOR SPIRIT OF ROSELLE PARK A tiempo completoThe Senior Consultant ERP Assurance plays a key role in designing and assessing the efficiency of IT Application Controls across the company's IT landscape. This role is exposed to senior stakeholders at all levels, both internal and external. About the Role Key responsibilities: Co-design, improve and drive the efficiency and effectiveness of Novartis IT...
-
distrito federal, México TC Energy A tiempo completoDetermined. Imaginative. Curious. If these are some of the ways you describe yourself — we want to learn more about you! At TC Energy, we are Energy Problem Solvers — passionate about transitioning North America to cleaner energy while meeting the energy demands of today and tomorrow. If that sounds like a challenge you want to help tackle, we want you...
-
HSBC | Senior Audit Manager | distrito federal
hace 3 semanas
distrito federal, México HSBC A tiempo completoJob Description If you’re looking for a career where you can make a real impression, join our Global Service Center HSBC and discover how valued you’ll be. We are currently seeking an experienced professional to join our team in the role of Senior Audit Manager Commercial Banking . Lead the preparation of individual audit plans to ensure that the scope,...
-
Associate Manager of Legal
hace 4 semanas
distrito federal, México Arthrex A tiempo completoAssociate Manager of Legal & Compliance - LATAM North Main Objective: The Manager of Legal & Compliance – LATAM North will play a pivotal role in ensuring Arthrex operates in full compliance with all applicable laws and regulations throughout the LATAM North region. This strategic leadership position entails overseeing legal and compliance initiatives in...
-
Senior Manager, Reporting and Analytics
hace 1 mes
distrito federal, México GlaxoSmithKline A tiempo completoSite Name: Poznan Grunwaldzka, Mexico City Torre Mitikah, Mississauga Milverton Drive Posted Date: Oct 31 2024 Senior Manager, Reporting and Analytics The Global Regulatory Operations Reporting Senior Manager at GlaxoSmithKline (GSK) is responsible for leading and managing the development, implementation, and maintenance of reporting services that support...
