3 Regulatory Experience Jobs

As a Regulatory Affairs Coordinator at Cipla, your primary responsibility is to ensure timely approvals from the FDA (Loan License units) by effectively coordinating with internal stakeholders and FDA teams for the submission of various applications. Your role also involves developing strong relationships with external stakeholders and advocating for licensing approvals for Cipla LL products. Your key accountabilities include: - Securing timely regulatory approvals from State FDA and CDSCO offices for loan license units, which includes obtaining approvals for various applications such as fresh loan licenses, additional product permissions, test licenses, India Business Tender Certificates, WHO-GMP, COPP, etc. - Coordinating with internal stakeholders to ensure timely applications and resolution of queries for approvals. - Maintaining a master tracker list of all permissions/approvals for the FDA (LL) team. - Building and maintaining relationships with external stakeholders in FDA and CDSCO offices. - Monitoring the timely release of CMCL for local and export markets, ensuring compliance with regulatory requirements and pharmacopeial changes. - Addressing major challenges such as obtaining India Business Tender Certificates, test licenses, and timely FDA permissions and label artwork approvals to support the Tech transfer team. In this role, you will interact with various departments including QA, R&D, FDA coordination team, and Regulatory Affairs. Additionally, you will engage with Deputy Drug Controller CDSCO, Assistant Drug Controller, Assistant Drug Inspectors, and Drugs Inspectors. Your key decisions will involve various FDA/CDSCO applications and submissions at state FDA/CDSCO offices, as well as strategizing for key license approvals in consultation with your Reporting Manager. To excel in this role, you should possess a B.Sc./B.Pharm degree, have good coordination and communication skills, regulatory experience, and 5-10 years of experience in the pharmaceutical industry. Join us at Cipla and contribute to ensuring smooth regulatory approvals for our loan license units and fostering positive relationships with external stakeholders.,

Whether you're at the start of your career or looking to discover your next adventure, your story begins here. At Citi, you'll have the opportunity to expand your skills and make a difference at one of the world's most global banks. We're fully committed to supporting your growth and development from the start with extensive on-the-job training and exposure to senior leaders, as well as more traditional learning. You'll also have the chance to give back and make a positive impact where we live and work through volunteerism. Citi's Risk Management organization oversees Citi's risk governance framework and risk appetite, ensuring all risks generated by the firm's businesses are measured, reviewed, and monitored on an ongoing basis. We're currently looking for a high caliber professional to join our team as Vice President, Credit Review Officer - Hybrid (Internal Job Title: Vice President - C13) based in Mumbai, India. Being part of our team means that we'll provide you with the resources to meet your unique needs, empower you to make healthy decisions, and manage your financial well-being to help plan for your future. About the team: Global Risk Review (GRR) provides independent, objective, reliable, valued, and timely assurance to the Boards, the Committees, the Citigroup Chief Risk Officer, the Citigroup Chief Credit Officer, senior management, and regulators over the effectiveness of credit, capital, and collateral risk management. Within GRR, as part of the Banking & International Credit Review (BICR) Team, the Credit Assurance & Loan Review Mechanism (CALRM) function provides an independent review and challenge of credit risk management. In this role, you're expected to: The Credit Review Officer - CALRM is responsible for independently managing the execution of Reviews in accordance with the CALRM Procedures Manual, monitoring and evaluation of Citibank N.A. India Corporate Bank, Commercial Bank, Global Wealth and Markets portfolios, strategies, and credit risks. You will assess the effectiveness of credit risk management, propose pragmatic solutions to risk and control issues, and maintain ongoing contact with Citibank N.A. India senior management through continuous Monitoring, Reviews, and corrective action follow-up. Responsibilities include: - Assessing the effectiveness of credit risk management at Citibank N.A. India - Assisting in the management of Citibank N.A. India portfolio through ongoing testing and periodic Reviews - Evaluation of the quality of the portfolio and relationships, including identification and evaluation of emerging risks - Assessment of the quality and adequacy of credit analysis, ongoing credit management, risk ratings, and classifications of corporate, commercial, and high-net worth relationships - Preparation of Credit Assessment Documents and completion of relationship-level file testing - Evaluation of Corrective Action Plans resulting from Reviews and subsequent validation of their effectiveness - Accountability for the quality and consistency of work products - Proactive communication with senior management regarding concerns and emerging risks Skills and Qualifications: - 8+ years of credit experience in corporate or commercial banking - Regulatory experience or relevant experience in Credit Loan Review Mechanism - Good knowledge of capital markets products and risk analysis - Advanced analytical skills and project management skills - Ability to recognize emerging risks and build relationships - Excellent written and verbal communication skills - Proficiency in Microsoft Office - BA/BSc or higher in business, finance, or a related field - Senior Credit Officer qualification preferred Working at Citi is far more than just a job. A career with us means joining a family of dedicated people from around the globe. You'll have the opportunity to grow your career, give back to your community, and make a real impact. Take the next step in your career and apply for this role at Citi today.,

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Business Sys. Analysis Sr. Specialist to join our team in Bangalore, Karn?taka (IN-KA), India (IN). Requirement 1 (Offshore): Role Specifics : This resource is backfill on the Fixed compliance gaps project in regulatory. The incumbent BA has been moved onto a higher priority NDA'd project and this topaz is to provide backfill. Work will be liaise with business owners and stakeholders to document existing business process, conduct a gap analysis to see if there are any areas where VM is out of compliance with OFCOM rules. Then document the requirements for change to ensure compliance Key Skills : Stakeholder management, excellent interpersonal skills, process mapping and gap analysis, requirements management and documentation Key Experience : Regulatory experience (especially OFCOM), business process mapping, Waterfall and Agile project experience Responsibilities Business process design and improvement Mapping customer journeys Analyzing, documenting and managing business requirements and providing functional assurance Workshop planning and facilitation Change planning and conducting impact assessment BA deliverables planning and management Building, managing and validating Requirements Traceability Understanding of delivery methodologies such as waterfall and agile Communications planning and management General understanding of business systems and networks Preparing user acceptance test scenarios and scripts Producing and presenting reports, business cases and other client deliverables Assisting with the creation of presentations and other materials for end user training. Interacting with clients, both internal and external, to supply information. Primary and secondary research gathering. Able to demonstrate experience of working as a business analyst in a major consultancy and the ability to demonstrate core consulting values An understanding of core telecommunication business processes and appreciation of telecommunication & media market trends Excellent client facing skills Working collaboratively with clients to deliver a first class service Experience and understanding of end to end system integration deliveries A sound approach to problem solving and can adapt rapidly to changing situations. A very high standards of written, spoken and presentation skills in English Knowledge of the change control process and the ability to analyze change to minimize impact on requirements and implementation About NTT DATA NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at NTT DATA endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click . If you'd like more information on your EEO rights under the law, please click . For Pay Transparency information, please click.