516 Regulatory Guidelines Jobs - Page 14

About Company BDO is a global professional services organisation and a leader in the mid-tier market, with a presence in over 166 countries and territories and a workforce of more than 119,611 people across 1800 offices. As part of this global network, BDO India offers a broad range of services, including Tax, Assurance, Accounting, Outsourcing, Advisory, and Technology-led solutions for both domestic and international clients across a variety of industries. Our commitment to innovation allows us to deliver high-quality, value-driven solutions that are adaptable to the rapidly changing business landscape. By staying ahead of industry trends, we ensure that our clients are equipped with the t...

Job Description QA / Sr. QA Analyst (Treasury, Derivatives, Murex, Kondor with Core Banking Position Type: Full Time Location: Bengaluru / Mumbai (Work from Office 5 Days) Interview Mode: Virtual Experience: 2 6 Years Notice Period: Immediate to Maximum 30 Days Role Overview We are looking for an experienced QA / Sr. QA Analyst with strong expertise in Treasury, Derivatives, Murex, and Kondor along with Core Banking experience . The ideal candidate should be proficient in manual/functional testing of Treasury modules, FX, MM, Repo, Swaps, and Derivatives, with recent project exposure (within last 2 years). Key Responsibilities Analyze functional requirements from BRD documents. Prepare, revi...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

As a Pharmacovigilance/Senior Pharmacovigilance Associate at ICON plc, you will play a crucial role in reviewing and processing safety events, including pre-marketing, post-marketing, medical device, and drug-related information. You will be responsible for conducting safety reviews of clinical and diagnostic data, generating data listings from the safety database, and ensuring the accuracy and quality of the data. Additionally, you will support the development of safety management plans, post-marketing safety activities, and participate in safety-related meetings and teleconferences. Your key responsibilities will include collaborating with cross-functional teams to support safety-related i...

As an experienced professional with a minimum of 15+ years of relevant industry experience in API (Bulk Drugs), your role will involve leading, planning, and monitoring the day-to-day activities of the Warehouse. You will be responsible for maintaining API, Bulk drugs, and Chemical warehouses in compliance with ISO, cGMP, and regulatory guidelines. Your key responsibilities will include preparing and leading the department during Financial Audits, conducting Yearly Stock Audits, and maintaining Monthly Stock Statements. You will also be involved in the preparation of stores SOPs, monthly planning with production, and coordinating with the planning department. Furthermore, you will be account...

The role of Associate at Tarun Kumar Gupta & Co. is a full-time on-site position based in Shahkot, Jalandhar, Punjab. As an Associate, you will play a crucial role in supporting various client projects by conducting research, preparing reports, and managing daily tasks related to client accounts. Additionally, you will collaborate with senior team members to execute strategies for client growth and ensure compliance. To excel in this role, you should possess strong analytical and research abilities, along with proficiency in report preparation and client account management. Effective communication skills, both written and verbal, are essential. You should be capable of working independently ...

The Senior Analyst-Treasury Operations position in the Treasury Backoffice department requires you to be responsible for processing Treasury FX and Merchant transactions, specifically Interbank and Merchant FX transactions. Your role involves scrutinizing these transactions in accordance with regulations and internal SOPs before validation. To excel in this role, you must possess a strong understanding of Forex, regulatory guidelines, relevant clauses in the back paper used for validation, and settlements. Your key responsibilities include: - Validation of various FX products such as CTS, Forwards, Loans, and deposits by verifying pre-deal requirements and deal parameters agreed upon by the ...

You are looking for a Senior Manager/AVP position in Credit Compliance at a bank in Mumbai. With 3-9 years of experience, you will be responsible for various key tasks related to regulatory compliance within the credit department. Your role will involve reviewing credit proposals presented to the Credit Committee, ensuring regulatory consistency, and highlighting any discrepancies. You will also evaluate credit policies, processes, and notes to provide feedback and advice for comprehensive and compliant bank operations. In this position, you will support the bank's business and credit functions by offering guidance on credit and lending matters from a compliance perspective. This includes ad...

As an Intern in CMC (Formulation) at Ferring India FHPDC R&D, you will be part of the CMC (Formulation) department in Hyderabad for a duration of 12 months. Reporting to the Lead Scientist - CMC (Formulation), you will receive a stipend for your work. To qualify for this position, you should have a Masters degree in Pharmaceutical Sciences (Pharmaceutics) or a related discipline from a reputable institution. A strong academic background in pharmaceutics is essential, along with basic knowledge of formulation principles and analytical techniques. Familiarity with regulatory guidelines such as ICH, FDA, and EMA is advantageous. Proficiency in MS Office (Word, Excel, PowerPoint) and scientific ...

To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account. Varex Imaging, headquartered in Salt Lake City, USA, is a leading innovator, developer, and manufacturer of X-ray imaging component solutions, which includes X-ray tubes, digital flat panel detectors, software, and other key components of X-ray imaging systems. With a 70+ year history of successful innovation, you will find our components in numerous medical, industrial, and security imaging applications worldwide. Through the talent of our people and vision of customers, we help improve and save lives throughout the world by...

The Third Party Management Program Execution provides operational support, process guidance, and quality assurance and quality control oversight to businesses across Citi, leveraging a central utility infrastructure, standardized processes, and operating procedures to execute robust risk management activities throughout the third-party management life cycle. As a Project Specialist 2, you will be responsible for performing relatively complex assignments with a direct impact on the business by ensuring the quality of the tasks or services provided. You will work under little to no direct supervision and may service an expansive and/or diverse array of products/services. It is essential to app...

As a Lead Clinical Trial Participant Recruitment, you will be responsible for managing and overseeing all aspects of participant outreach, screening, scheduling, engagement, and follow-ups for ongoing and upcoming clinical studies. Your role will involve supervising the recruitment team, ensuring timely and ethical enrollment of subjects, and maintaining consistent communication throughout the trial journey. You will design and implement effective outreach strategies across digital platforms, local communities, and healthcare networks. Identifying and engaging eligible participants in line with study inclusion/exclusion criteria will be a key responsibility. Additionally, you will supervise ...

The Group Leader -GCP QA (Clinical) at Syngene in Bangalore is responsible for managing the GCP QA auditors team and conducting various audits related to clinical research, process audits, Investigational Site audits, and safety database audits. The role involves assessing systems and practices to improve the GCP Quality System practices in alignment with the national and international GCP Quality System standards. The Group Leader must ensure compliance with quality (GxP) regulations and standards, making the facility audit-ready at all times. Key Responsibilities include: - Scheduling and conducting GCP QA audits to ensure compliance with regulatory requirements - Developing risk-based aud...

Rubicon Research Limited is a rapidly growing pharmaceutical formulation company focused on developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. With a diverse product portfolio of over 250 SKUs spanning more than 70 product families, we have established marketing, sales, and distribution platforms in the US through our subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. Our US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities, demonstrate our commitment to quality and innovation. As ...

As a Clinical Trials Assistant, you will play a crucial role in supporting various aspects of clinical trials. Your responsibilities will include assisting in site selection, initiation, monitoring, and close-out visits for clinical trials to ensure their successful implementation. It will be your responsibility to ensure that all clinical trials are conducted in compliance with the protocol, ICH-GCP guidelines, and regulatory requirements. You will be tasked with maintaining accurate and proper documentation of all trial activities and reporting findings effectively. Your role will also involve supporting data verification by meticulously comparing source data with Case Report Forms (CRFs)....

You will be responsible for providing analytical support for developmental projects/comparative dissolution projects received from client sites. This includes being an interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations. You will coordinate with CRO to ensure that projects are completed within the timeline. Additionally, you will design scientific experiments, monitor lab work, and recommend further investigations based on experimental results. Your role will involve the preparation of test methods, technical documents, protocols, and reports when necessary. It is crucial to record information accurately, retain rec...

As a Senior Wealth Manager, you will be responsible for guiding high-net-worth individuals and institutional clients in managing and growing their wealth. You will develop personalized financial plans, manage investment portfolios, and provide guidance on tax strategies, risk management, and estate planning. With your expertise in market analysis and a deep understanding of clients" goals, you will offer comprehensive financial advice to optimize wealth growth and achieve long-term financial success. Key Responsibilities: - Managing and growing a client base focused on HNI/UHNI and affluent retail segments. - Driving sales of equities, mutual funds, insurance, and third-party investment prod...

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, support...

The role of Instrument Calibration Technician involves performing and documenting calibration of instruments and equipment at a pharmaceutical site to ensure compliance with cGMP, regulatory guidelines, and customer requirements. It is crucial to maintain accuracy and compliance standards to support pharmaceutical production and quality. Responsibilities include conducting on-site calibration of various process control instruments such as temperature sensors, pressure gauges, flow meters, humidity and temperature data loggers, weighing balances, and others. Calibration must be carried out following approved SOPs, master schedules, and work instructions. Collaboration with Quality and Enginee...

We are seeking skilled and dedicated individuals to join our Quality Assurance (QA) department at Fido Pharma Private Limited, an esteemed pharmaceutical company located at Plot No: 108-109, Global Industrial Park, Mauli, Barwala, Panchkula, Haryana. If you have a background in B.Pharm / M.Pharm / M.Sc. and a passion for ensuring quality in pharmaceutical products, we have the following positions available: QA Manager: As a QA Manager, you will lead our Quality Assurance department, overseeing adherence to GMP and regulatory guidelines such as EU-GMP and WHO-GMP. Your responsibilities will include managing document control, validations, change control, Vendor Qualification, CAPA, deviations,...

You are invited to apply for the position of "Senior Relationship Manager-MMG" in a renowned bank located in Bangalore. As a Senior Relationship Manager, you will be responsible for sourcing New to Bank (NTB) clients in the mid and large corporate segment with turnovers ranging from Rs. 250 crores to Rs. 5000 crores. Your role will involve establishing and leveraging contacts with promoters, CEOs, CFOs, and Heads of Treasury across diverse industries such as Pharma, textile, auto, steel, FMCG, agriculture, retail, Infrastructure, chemicals, power, dairy, cement, and paper, among others. Your duties will also include resolving queries from the risk team and facilitating the entire process to ...

Join UAE's largest bank and one of the world's largest and safest financial institutions. The focus is on creating value for employees, customers, shareholders, and communities to grow through differentiation, agility, and innovation. The organization is looking for top talent, where your success is considered the organization's success. Accelerate your growth by helping to reach goals and advance your career. Be prepared to make your mark at a top company in an exciting and dynamic industry. To perform all functions of Trade Finance, Cash Management, Corporate Loans and Deposits, Borrowing, and settlement from the group while adhering to related regulatory guidelines and internal processes....

Amgen is dedicated to leveraging the power of biology and technology to combat the most challenging diseases worldwide, while enhancing the quality and longevity of people's lives. For over 40 years, Amgen has been at the forefront of the biotechnology industry, utilizing cutting-edge innovation, technology, and genetic data to expand beyond current boundaries of knowledge. As the Scientific Communications Therapeutic Area (TA) Lead at Amgen, you will be responsible for overseeing the planning, resource management, and implementation of scientific communications deliverables, including medical content and publications, for a specific disease area or key product(s) within the assigned Therape...

You will be responsible for screening and sampling activities in Consumer Bank - Retail Asset(s), as well as pre and post-verification activities. Your role will involve managing a team and vendors to drive field-level initiatives, activities, and enquiries. Additionally, you will be handling MIS and bill processing for respective vendors. It is expected that you take additional initiatives and be willing to travel outside the base location. As part of your duties, you will assess credit reports, credit scores, and other relevant financial data to determine creditworthiness. You must ensure compliance with internal policies and external regulations governing mortgage lending. To be considere...

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier ...