21 Regulatory Guidance Jobs

As an Associate at Ares, your primary role will involve supporting the company's compliance with marketing materials policies. Your responsibilities will include: - Providing primary compliance marketing review support for various marketing materials such as DDQs, RFPs, webinars, quarterly and annual reports to ensure compliance with regulatory guidance and Ares Marketing and Advertising policy. - Communicating issues and escalating them as needed with Compliance Leadership. - Monitoring all submissions of materials in a timely manner and ensuring high quality and timely reviews. - Assisting with marketing review system administration, including onboarding, training, workflow management, and...

As a Regulatory Compliance Officer for the treasury function of the Bank, your role involves providing regulatory guidance on products, processes, and transaction structures. You will be responsible for interacting with regulators, preparing Management Information Systems, and ensuring compliance with the latest regulations. Key Responsibilities: - Provide regulatory guidance on business structures and transactions related to treasury and PD operations. - Review product and process notes from a regulatory perspective. - Regularly interact with regulators for clarifications and approvals. - Implement the latest regulations within prescribed deadlines. - Prepare and circulate accurate Manageme...

This is where your work makes a difference. At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. He...

We are seeking a senior strategist to own Product Planning and Innovation for our skin care business. The incumbent will directly manage end-to-end product pipeline with full ownership of white-space concepting, consumer insights, assortment architecture, and new-concept incubation for our fast-growing skin-care portfolio. Ideal candidate will convert deep market intelligence into differentiated product pipelines, partnering closely with R&D, Brand and Regulatory to deliver clinically proven, trend-right innovations at pace. The Product Planning and Innovation Head will be the organization's thought leader on emerging ingredients, technologies and trends and bridge the gap between business g...

As an individual in Quality Assurance, Monitoring & Testing at our company, you will be responsible for assessing outcomes from activities and processes against applicable requirements to enhance risk management quality. This includes conducting quality testing for business function quality control and transformation lead quality control post activity/process completion. Your role will involve developing and executing Monitoring and Testing for controls, such as control design assessment, operational effectiveness design, monitoring/testing tool assessment, and executing monitoring/testing tools to evaluate key controls addressing defined risks. Your key responsibilities will include: - Ensu...

As an Associate Customer Service Trade Finance at Deutsche Bank, you will be an integral part of the Relationship & Transaction Management (RTM) team in the Corporate Bank. Your role will focus on providing top-quality support to Corporate clients in the US for various trade-related transactions such as Trade/Trade Loans/Supply Chain Finance. In addition to this, you will be responsible for conducting product-based training for clients, setting up/service of supply chain Finance module & Risk Management solutions. Your key responsibilities will include: - Coordinating Trade Transactions internally with operations, compliance, product, and other stakeholders, as well as engaging with clients ...

As a Company Secretary at A-One Steel in Bangalore, you will play a crucial role in ensuring corporate governance, legal compliance, and strategic advice to the Board of Directors. Your responsibilities will include: - Corporate Governance: - Advise the Board of Directors on corporate governance matters, ensuring compliance with laws and best practices. - Develop and implement corporate governance policies and procedures. - Oversee corporate social responsibility initiatives. - Legal and Compliance: - Provide legal and regulatory guidance to the Board and management. - Ensure compliance with relevant laws such as the Companies Act, 2013, and SEBI regulations. - Manage legal and regulatory ri...

As a Senior Clinical Data Associate at our company, you will play a crucial role in providing support and assistance throughout the clinical trial data management process for assigned projects. Your responsibilities will include: - Supporting the Lead DM as a back-up or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies when necessary - Conducting quality control of data entry - Providing input into timelines and assessing resource needs for projects - Developing CRF specifications and coordinating feedback from stakeholders - Assisting in building clinical databases and conducting database build UAT - Specifying requirements for variou...

Job Description: As a Medical-Regulatory Writer Assistant Manager, your main responsibility will be to plan and manage Medico-Regulatory Writing in accordance with relevant Regulatory Guidelines. You will be expected to deliver high-quality medical and scientific writing, provide technical consultation and advice on strategy and regulations, demonstrate subject matter expertise, effectively manage writing projects to meet deadlines, collaborate with internal and external clients, and produce various types of reports including CTD Modules, Safety Reports, and Aggregate Reports. Key Responsibilities: - Conduct science reviews of aggregate reports - Ensure document compliance with client specif...

As a candidate with 8 to 12 years of experience in the Commercial vehicle profile, your role will involve the following responsibilities: - Monitor, study, and summarize upcoming vehicle regulations (domestic and international). - Analyze and interpret Indian and global automotive regulatory requirements. - Provide regulatory guidance and impact assessments to internal stakeholders on forthcoming regulations. - Act as a liaison with industry associations and regulatory bodies (e.g., SIAM, ARAI, BIS) during regulation formulation. - Represent the organization in regulatory and industry forums, ensuring alignment with evolving standards. - Prepare and deliver clear, insightful presentations on...

Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, Safety Update Reports, Canadian Annual Reports, etc.), responses to regulatory queries on safety topics, post-market...

As a member of the Business Data Intelligence Team in the Tax Department, your role will involve working with a global team to drive strategy and maintain the integrity of the firm's compliance with reporting authorities worldwide. Your responsibilities will include accurate and timely account documentation, monitoring, client information reporting, regulatory filings, and providing subject matter expertise during system implementation. You will have the opportunity to optimize procedures through data analytics and technology use. Key Responsibilities: - Work with senior management and teams across regions to drive initiatives and issue resolution - Develop expertise in tax systems and requi...

As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Maste...

Position: Sr. Manager / AGM Regulatory Affairs Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience: 1316 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory compliance/audit support. The role ensures accurate and compliant representation in dossiers, while guiding strategy for regulatory filings, variations, and lifecycle management across multiple regions. Key Responsibilities Deep expertise in vaccine/biological regulatory affairs, dossier preparation, and lifecycle management. Strong track reco...

Tax Compliance & Filings: Manage preparation and filing of various tax returns with IRAS, including: Estimated Chargeable Income (ECI) Final Tax Returns (Form C / Form C-S / Dormant Company Waivers) GST Returns Withholding Tax Returns Assist with applications for Certificate of Residence (COR) on behalf of clients. Liaise with IRAS to address and resolve tax audits related to GST, income tax, and withholding tax. Regulatory & Secretarial Support: Prepare and review corporate secretarial documents including statutory registers, board resolutions, AGM documentation, and related compliance filings. Provide end-to-end assistance with short-form amalgamation of companies in Singapore. Fund & Ince...

ICON plc is a world-leading healthcare intelligence and clinical research organization that fosters an inclusive environment driving innovation and excellence. As the Senior Manager of Group Accounting & Reporting in the ICON Group accounting team, you will support internal and external reporting under US GAAP & IFRS. Your role will involve providing technical accounting leadership to the wider group finance teams and senior leadership teams. You will be responsible for preparing group annual reports under US GAAP & IFRS, as well as reporting quarterly financial information to the stock exchange under US GAAP. Additionally, you will prepare monthly consolidated group management information f...

Individuals in Quality Assurance, Monitoring & Testing are responsible for assessing outcomes from activities and processes against conformance with applicable requirements to strengthen risk management quality. This involves quality testing for business function quality control and transformation lead quality control post-completion of an activity/process. It includes the development and execution of Monitoring and Testing for controls, such as control design assessment, operational effectiveness design for monitoring & testing tools, monitoring/testing design assessment, and execution of monitoring/testing tools to assess the effectiveness of key controls designed to address defined risks....

Precision for Medicine is looking for a skilled Medical Coder to provide comprehensive Coding and related data management support during all phases of the clinical trial data management process. Working under direct supervision with a team of medical coders, you will ensure compliance with Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role involves various responsibilities, including data coding, quality review, and collaboration within a dynamic team environment. The Coder will be responsible for providing Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full-time basis. They will follow Standard Operating Procedures/Work...

Provide expert advice on product development, regulatory strategy, and market analysis to life sciences clients. Job Summary: We are seeking a knowledgeable Life Science Consultant to provide expert guidance on product development, regulatory strategy, and market analysis for clients in the life sciences sector. The ideal candidate will combine scientific expertise with strategic insight to deliver impactful solutions that drive innovation and business growth. Key Responsibilities: Advise clients on product development strategies and lifecycle management. Provide regulatory guidance and support for compliance with local and global standards. Conduct market research and competitive analysis t...

Are you looking for an opportunity to be part of a growing organization and work as part of a global team to drive strategy in a constantly changing environment We are looking for a professional with experience in the financial industry to join Business Data Intelligence Team in the Tax Department. Tax analyzes and supports the activities, operations, reporting obligations, and transactions of the firm's business lines to ensure that tax consequences and reputational risks are evaluated appropriately. The work directly contributes to the firm's success, making it ideal for creative and collaborative individuals who have strong ethics and attention to detail. The team is responsible for maint...

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corp...