6 Regulatory Systems Jobs

Let's do this. Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master's/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor's degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor's degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency

As a Software Engineer III in the Security Engineering Development team at Walmart Global Tech, you will play a crucial role in developing software products and services in the field of cyber security. Your primary responsibility will be to leverage your strong background in technology and security awareness to address some of the most unique cyber security challenges in the industry. The ideal candidate for this role should possess a solid software development experience encompassing both front end and backend technologies, including integration with backend REST APIs, working with backend databases, and exposure to the cyber security domain. In the role of Risk Expert III, you will work under the guidance of Team Leadership to execute goals and objectives related to monitoring control health in regulatory systems. Your responsibilities will include identifying new or modified scopes of regulatory systems requiring control health monitoring, engaging with key stakeholders to understand control requirements, integrating regulatory systems into the monitoring platform, and collaborating with technical teams to address control health anomalies promptly. Additionally, you will assist in documenting control requirements for automation, supporting assessments of regulatory systems, and identifying improvement opportunities to enhance control health. To excel in this role, you should possess experience in assessing, designing, and implementing IT processes and controls. Familiarity with retail and regulatory compliance systems, along with a good understanding of IT regulatory standards and frameworks such as COBIT, ISO 27001, and ITIL, will be advantageous. A methodical problem-solving approach, strong initiative, collaborative skills, and excellent communication abilities are essential for success in this position. Certification in a relevant risk field (such as CISA, CGEIT, or CRISC) is considered a plus. At Walmart Global Tech, we are committed to creating an inclusive culture where every associate feels valued and respected. We prioritize fostering a sense of belonging and providing opportunities for all associates, customers, and suppliers. As an Equal Opportunity Employer, we embrace diversity and believe that understanding, respecting, and valuing individual differences leads to a more engaging and successful workplace. Join us at Walmart to be part of an innovative team that is shaping the future of retail and making a positive impact on millions of lives.,

As a Business Analyst at YouTube, you will play a crucial role in the Trust & Safety team, working towards making YouTube a secure platform for users, viewers, and content creators worldwide. Your responsibilities will involve utilizing data and problem-solving techniques to define success metrics for Trust and Safety operations, measure business performance, and effectively communicate insights to executives and external stakeholders. You will collaborate with key business partners to understand data requirements, write Extract, Transform and Load (ETL) scripts, and work closely with internal teams to drive operational excellence. Your expertise will be instrumental in toggling between high-level strategic perspectives and day-to-day tactical improvements to enhance business performance and efficiency, such as implementing automation using classifiers and tools to expedite the removal of violative content. Furthermore, you will be tasked with developing, building, and evaluating performance metrics for abuse prevention and operational efficiency across YouTube, generating insights to reduce the prevalence of harmful content on the platform. Your role will also involve learning complex technical concepts and systems, effectively communicating technical results and methods, and collaborating with Data Science and Strategy teams to conduct advanced quantitative analyses that lead to actionable insights. Additionally, you will analyze existing processes to identify opportunities for enhancement, define requirements for improvement, and work collaboratively across functions and regions to optimize processes and tools. Your analytical skills will be crucial in analyzing and addressing escalations, identifying trends that may indicate potential product risks, and contributing to the continuous improvement of YouTube's Trust & Safety operations. Overall, as a Business Analyst at YouTube, you will be at the forefront of safeguarding the platform, supporting its mission to represent diversity, foster community, and empower individuals to share their stories and connect with others worldwide.,

As a Functional Data Modeler in the Mutual Fund industry, you will play a vital role in designing data models that accurately represent fund structures, NAV calculations, asset allocation, and compliance workflows. Your expertise in data modeling, combined with a deep understanding of mutual funds and BFSI domains, will be instrumental in creating schemas that meet operational and regulatory requirements. Your responsibilities will include collaborating with business analysts and product teams to translate functional requirements into effective data structures. It will be crucial for you to ensure that the data models you design comply with data privacy regulations, regulatory reporting standards, and audit requirements. Additionally, you will be responsible for building OLTP and OLAP data models to support real-time and aggregated reporting needs and documenting metadata, lineage, and data dictionaries for business use. To excel in this role, you must have a strong domain expertise in Mutual Fund/BFSI operations and a proven track record in data modeling for financial and regulatory systems. Proficiency in schema design on GCP platforms such as BigQuery and CloudSQL, as well as hands-on experience with modeling tools like DBSchema or ER/Studio, are essential skills required for this position. Preferred skills for this role include experience working with fund management platforms or reconciliation engines and familiarity with financial compliance standards such as SEBI and FATCA. Soft skills like strong business acumen and effective documentation capabilities will also be valuable in liaising between functional and technical teams successfully. By joining our team, you will have the opportunity to own critical financial data architecture, influence domain-driven modeling for financial ecosystems, and be part of a fast-paced data transformation journey in the BFSI sector. If you are looking to make a significant impact in the field of data modeling within the mutual fund industry, this role is perfect for you.,

The role of VP - Regulatory Reporting at OakNorth Bank is an individual contributor role based in Gurugram ONGPL. As a new fast-growing bank in the UK, OakNorth Bank is a CRDV firm subject to a full suite of regulatory returns including COREP, FINREP, PRA/FSA, FCA returns, and BOE returns. The bank is in the process of implementing a new end-to-end regulatory reporting system, with the implementation expected to commence from June 2023. The ideal candidate for this role will be responsible for driving this project and fulfilling key responsibilities within the regulatory reporting domain. One of the key opportunities in this role is to learn all regulatory returns across capital, liquidity, and leverage. The Regulatory Reporting team is also accountable for daily liquidity reporting, ALCO reporting, and IRRBB reporting to support Treasury balance sheet management activities. With a diverse range of products and continuous new product launches, the candidate will be expected to research the regulatory impact and provide insights into new product development. Working in a small team, this role offers the opportunity to closely collaborate with individuals across all levels, teams, and locations, thereby contributing to team-building as the bank grows. The candidate will gain experience in various regulatory areas such as liquidity, credit, interest rate risk, treasury, and other balance sheet reporting. Furthermore, involvement in cross-functional projects and exposure to new product initiatives during the bank's growth phase are additional highlights of this role. Key responsibilities include producing liquidity, credit, and banking exposure reports, handling balance sheet driven returns, managing capital and RWA returns, ensuring compliance with regulations and SOPs, preparing management information, supporting the production of treasury ALCO packs, and maintaining reporting integrity. The candidate will also be responsible for governance tasks such as maintaining finance team governance tracker, SOP updates, audit/regulatory action tracking, and responding to regulatory queries. The ideal candidate should possess very strong Excel skills, data analytical skills, and problem-solving abilities. A minimum of 5+ years of post-qualification experience in Regulatory Reporting, particularly Basel Reporting - Liquidity, Capital, and RWA reporting, is required. Experience in the Financial Services industry, particularly in the UK Regulatory (PRA/BOE), Treasury, Risk management, or related fields is essential. Strong communication skills, adaptability to change, a control mind-set, and a keen learner attitude are also expected from the candidate. Academically, a degree qualification in Accounting/Finance and graduation/post-graduation from a top-rated college/CA/MBA Finance/CFA/FRM/PRM/ACT is preferred. About OakNorth Bank: OakNorth Bank empowers entrepreneurs to realize their ambitions, understand their markets, and apply data intelligence to scale successfully at pace. The bank's belief in barrier-free banking is inspired by its entrepreneurial spirit, unmet financial needs, and data-driven tools. OakNorth Bank strives to create an inclusive and diverse workplace where individuals can thrive professionally and personally. The bank's story is rooted in frustrations with traditional banking, leading to the establishment of a bank founded by entrepreneurs, for entrepreneurs, offering a better borrowing experience for businesses.,

As the Senior Manager of Regulatory Data Management in Hyderabad, you will be instrumental in shaping and implementing the system-based framework for regulatory data management at Amgen. This pivotal role involves leading the Data Management team within Amgen India (AIN), engaging with GSIM leadership, and collaborating with cross-functional partners who utilize the company's Regulatory Information Management (RIM) system. You will be responsible for building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance. Roles & Responsibilities Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system. Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement. Ensure the team meets key operational metrics and compliance standards , maintaining high levels of accuracy and efficiency. Drive continuous improvement initiatives to enhance service delivery and operational processes. Minimize potential errors by establishing policies & processes for data usage. Supervise the provision of high-quality data processing, system utilization, and data management services to global clients. Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices. Stay abreast of regulatory developments and ensure the team follows all relevant regulations and standards. What We Expect of You Basic Qualifications Doctorate degree and 2 years of regulatory systems experience OR Master's degree and 8 to 10 years of regulatory systems experience OR Bachelor's degree and 10 to 14 years of regulatory systems experience OR Diploma and 14 to 18 years of regulatory systems experience Advanced knowledge of Veeva Vault RIM . Proven leadership in regulatory data management . Hands-on ability to work on data-centric processes and systems . Strong knowledge of handling structured and unstructured data. Demonstrated excellence in change management and key customer engagement . Preferred Qualifications Experience with delivering compliance assurance within a large company. Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry . 5 years of proven experience in regulatory operations, submission management . Excellent understanding of Regulatory Affairs business complexity and process interdependencies . Experience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area. Demonstrated experience in building and leading successful teams . Sharp learning agility and analytical thinking. Proven and advanced interaction with global key customers.