2920 Regulatory Requirements Jobs - Page 27

Role Overview: As a Medical Coder at Medical Billing Wholesalers, you will review medical charts and assign relevant CPT and ICD-10 codes to ensure accuracy based on coding and customer guidelines. Your responsibilities will involve proficiently coding outpatient/inpatient charts across various specialties with high levels of accuracy. It is essential to have a strong understanding of CPT and ICD-10 guidelines, perform necessary code edits, and actively participate in team activities to meet quality and productivity standards. Supporting billers and AR analysts, participating in industry meetings, and continuously enhancing coding standards are also part of your role. You will need to docume...

HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline, About The Role Key Responsibilities Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate ind...

You will be a part of the Technology Audit team in Gurgaon, Haryana and Mumbai, Maharashtra. Your main responsibility will be to assist in conducting technology audits and assessing technology risks across various departments within the organization. - Conduct technology audits to evaluate the effectiveness of technology controls - Identify and assess technology risks and provide recommendations for improvement - Collaborate with cross-functional teams to ensure technology compliance with regulatory requirements - Prepare audit reports and communicate findings to senior management Qualifications Required: - Bachelor's degree in Computer Science, Information Technology, or related field - Pre...

In this role as a Tech Risk & Controls Senior Associate / Assistant Vice President, you will play a crucial part in managing technology-related aspects of Governance, Risk, and Compliance in alignment with the firm's standards. Your broad expertise in risk management principles will be utilized to evaluate and monitor risks, implement effective controls, and enhance the firm's risk posture. By collaborating with cross-functional teams and leveraging your analytical skills, you will contribute to the overall success of the Technology Risk & Services team while ensuring compliance with regulatory obligations and industry standards. **Key Responsibilities:** - Lead comprehensive control evaluat...

As a TMF Reviewer at Fortrea, your role involves performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts and internal Fortrea business needs. Key Responsibilities: - Provide process, control, coordination, and approval of clinical trial documents. - Manage ECD, Phase I-IV electronic trial master file (eTMF). - Maintain an understanding of applicable regulatory requirements. - Manage electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, collaborating with key study personnel such as the Study Team Member. - Perform...

As a Cybersecurity Sales Professional with a minimum of 5 years of security background, you will play a crucial role in driving revenue growth for cybersecurity solutions and services. Your responsibilities will include: - Developing and executing sales strategies to increase revenue in cybersecurity solutions and services. - Identifying, qualifying, and pursuing new business opportunities in enterprise and mid-market segments. - Building and maintaining strong relationships with CISOs, IT Directors, and key decision-makers. - Responding to RFPs, RFIs, and creating compelling proposals tailored to customer needs. - Negotiating contracts, pricing, and terms to successfully close deals. In add...

As a Commercial Head at Cohance Lifesciences, you will play a crucial role in leading the Formulations (FDF) business globally, with a key focus on scaling operations to achieve a 1000 Cr market footprint. Your responsibilities will include: - Strategic Leadership: Develop and execute commercial strategies aimed at expanding the FDF business globally, with a specific focus on both US and non-US regulated markets. - Business Development: Drive growth through the establishment of strategic partnerships, client acquisition, and the expansion of CDMO formulation services. - Revenue Growth: Lead initiatives geared towards scaling the business to 1000 Cr by identifying high-potential markets and o...

As a Quality Chemist at the Water Treatment Plant (WTP) and Effluent Treatment Plant (ETP) team, your role will involve ensuring the quality of chemical processes and compliance with environmental standards. You will have the opportunity to contribute to the improvement of processes and resolution of quality issues. **Key Responsibilities:** - Conduct quality control tests on water treatment and effluent treatment processes. - Analyze chemical samples and interpret results to ensure compliance with standards. - Prepare reports and documentation on quality testing and findings. - Collaborate with engineering and production teams to improve processes and resolve quality issues. - Maintain labo...

As a Botanical Quality Control Specialist, you will play a crucial role in ensuring the quality and authenticity of botanical ingredients used in homeopathic formulations. Your responsibilities will include: - Botanical Sourcing and Evaluation: You will scout, assess, and establish relationships with botanical suppliers to maintain a consistent and high-quality supply of ingredients. It will be your responsibility to conduct detailed evaluations of botanical samples to verify their authenticity and potency. - Quality Assurance Testing: Your role will involve developing and executing comprehensive testing protocols to evaluate the purity, identity, and potency of botanical extracts. You will ...

As a Product Manager - Design and Development at ALAN Electronic Systems Private Limited, you will play a crucial role in overseeing the execution of the company's medical devices roadmap. Your responsibilities will involve leading cross-functional teams, coordinating with vendor ecosystems, and ensuring the strategic delivery of products in the medical devices domain. Your expertise in electronic medical devices, product development processes, and team management will be essential for the success of this role. Key Responsibilities: - Lead the full lifecycle management of medical devices, focusing on those used in surgical and OT settings. - Develop and execute a structured roadmap in collab...

You will be responsible for managing the financial operations and budgets of the company, ensuring compliance with regulatory requirements, and providing financial advice. Your role will involve conducting financial audits, analyzing risks, and preparing financial statements. Additionally, you will be involved in tax planning and filing, as well as detecting and preventing fraud. Key Responsibilities: - Continuous management of financial systems and budgets - Undertaking financial audits and providing financial advice - Reviewing the company's systems, analyzing risks, and performing tests on financial information - Tax planning and filing within current legislation - Maintaining accounting ...

Role Overview: As a QC Microbiologist, you play a crucial role in ensuring the quality and safety of products through microbiological testing. Your responsibilities include: Key Responsibilities: - Sampling and Analysis: Collect and analyze samples from raw materials, in-process, and finished products using microbiological techniques such as plate counting and molecular assays. - Quality Control Testing: Ensure that microbial levels meet regulatory specifications and product safety standards. - Environmental Monitoring: Monitor microbial levels in production areas to detect any contamination risks, including air, surfaces, and water systems. - Aseptic Techniques: Follow aseptic practices dur...

Job Objective Senior Scientist with expertise in oral liquid formulation development, manufacturing, and regulatory compliance, driving innovation and quality in pharmaceutical product development. With a passion about formulation and development for oral liquid. Age: 35 to 45 years Education: P.hd or related field Mandatory experience in Pharmaceutical Oral Liquid Formulation Role & responsibilities 1. Formulation Development: - Design, develop, and optimize oral liquid formulations for new and existing products. - Conduct pre-formulation studies, solubility testing, and stability assessments. 2. Product Development: - Lead cross-functional teams to develop and launch new oral liquid produc...

Ensure compliance with all applicable laws, labour regulations, and industry guidelines. Draft, review, and maintain legal documents, contracts, and agreements. Handle compliance audits and liaise with regulatory authorities. Required Candidate profile Strong knowledge of compliance, contracts, and legal framework. Attention to detail with analytical and problem-solving skills. Good communication and drafting ability. Location: Kolhapur Male only

Role Overview: You will support the Novartis Technical Operations (TechOps) Lifecycle Implementation team in leading and managing implementation product lifecycle projects such as launch, transfer, change, divestment, and pruning in compliance with Good Manufacturing Practices (GMP) & Regulatory requirements. Your main accountability will be to assist in the implementation of assigned product lifecycle projects/brands, deliver and maintain a detailed Change Over Plan (COP) for LC projects, collaborate with various stakeholders, ensure up-to-date assortment at SKU level, manage blocks, report deviations, collect and report KPIs, participate in continuous improvement initiatives, and complete ...

As a Quality Control Specialist at SUDARSHAN PHARMACEUTICALS PVT LTD in Indore, your role involves conducting quality control and quality assurance activities to maintain product quality standards. You will be responsible for implementing Good Manufacturing Practice (GMP) guidelines, managing quality processes, and conducting quality audits to identify areas for improvement. Your strong attention to detail and analytical skills will be crucial in identifying quality issues and proposing effective solutions. Collaboration with team members to achieve quality objectives and utilizing your knowledge of regulatory requirements in the pharmaceutical industry to ensure compliance with relevant gui...

As a Senior Auditor in the Operational Controls Testing Team, your role involves designing, performing, and managing periodic tests on various regulatory requirements and bodies. You are required to adapt regulatory and internal processes to efficiently create testing procedures. Communication of deviations to concerned Business Units and Testing leadership based on initial testing results is a crucial aspect of your responsibilities. Additionally, maintaining documentation for all tests, working on ad-hoc tasks and projects, and assisting in analysis and report generation for management are essential tasks. Your key responsibilities will include: - Independently managing and developing test...

As an eCompliance Manager at Novartis, your role involves providing Quality Assurance oversight and guidance regarding computerized systems validation (CSV) within the framework of regulations such as GxP, 21CFR11, and other relevant requirements outlined in the Novartis Quality Manual and global procedures. Key Responsibilities: - Oversight of operational activities of GxP systems including managing changes, periodic reviews, and deviations - Providing necessary support to ensure compliance with Novartis and regulatory requirements for GxP regulated computerized systems projects - Acting as the main point of contact for all CSV related matters for GxP Computerized Systems and bridging the g...

As a Senior Executive in the Research & Development team at Natural Biogenex Private Limited (NBPL), you will specialize in Downstream Processing of pharmaceutical intermediates and APIs. Your responsibilities will include designing, optimizing, and executing downstream processes to support the development of high-quality API products. You will play a crucial role in ensuring the quality, compliance, and accuracy of laboratory operations under cGMP and regulatory requirements. **Key Responsibilities:** - Monitor and control batches in the R&D Downstream Processing (DSP) laboratory - Ensure smooth execution of departmental R&D projects - Adhere to Good Laboratory Practices (GLP), Good Manufac...

As an Associate Engineer / Document Controller at the company, your role will involve supporting project documentation processes across all lifecycle phases. With a background in project management and document control, you will be responsible for maintaining compliance with Saudi Aramco standards and national/international regulations. Key Responsibilities: - Develop and implement comprehensive Document Control Procedures and archiving systems for engineering, procurement, and construction phases. - Maintain accurate and systematic filing structures, document logs, version tracking, and retrieval systems. - Prepare and maintain audit checklists to ensure contractor and vendor documentation ...

Role Overview: You will be responsible for coordinating, organizing, and managing external resources to ensure timely and effective completion of Engineering planned and breakdown maintenance activities. This includes attending daily meetings to prioritize tasks, maintaining a rolling planned maintenance schedule, defining and tracking Engineering materials and equipment, managing Engineering Maintenance and Calibration documentation, and supporting Engineering and new process projects by ensuring proper documentation. Additionally, you will procure and track Engineering parts and materials, ensure maintenance of qualifications or validations, comply with cGMP standards, and maintain all Eng...

As a Consultant to Senior Consultant in the Environmental Permitting and Compliance team, your role will involve supporting the delivery of environmental permit applications, associated studies, and compliance activities for the regulated industry sector in the UK. You will work across various industrial sectors such as energy, waste, food and drink, chemicals, and manufacturing. Your responsibilities will include: - Obtaining environmental permits for industrial facilities - Handling variations, transfers, and surrenders of existing permits - Managing permit applications for water discharge activities, flood risk activity permits, and trade effluent consents The projects you will be involve...

In this role as the Director - IT Technology Engineering and Innovation GDC at Micron Technology, Inc., you will lead the infrastructure teams, contribute to strategic vision, mentor IT professionals, and ensure seamless integration of technology solutions across the organization. **Key Responsibilities:** - Develop and implement strategic plans for IT infrastructure and innovation. - Lead and mentor a team of IT professionals, promoting excellence and innovation. - Manage services optimization to align with Micron's objectives. - Collaborate with cross-functional teams to ensure technology initiatives support business goals. - Introduce new technologies and standard methodologies to enhance...

As a Business Development Executive, you will be responsible for partnering with banks to generate EDC/SB/QR business from branches. Your role also includes owning and managing the EDC/SB base deployed via assigned branches, ensuring activation and quality of accounts, and utilizing product/technical knowledge for commercial purposes. It is essential to maintain high account management standards to guarantee merchant and bank team satisfaction, as well as to drive high standards of customer service and satisfaction for banking partners. Your key responsibilities will include: - Partnering with banks to generate EDC/SB/QR business from branches - Owning and managing the EDC/SB base deployed v...

As a Plant Head at the facility in Dahej, your role will involve overseeing the operations of the plant. Your experience in working with Pharma OSD (Tablet Capsule) will be crucial in ensuring the successful functioning of operations. **Key Responsibilities:** - Manage and oversee the day-to-day operations of the plant - Ensure compliance with regulations and quality standards in the production of Pharma OSD (Tablet Capsule) - Lead and motivate the plant staff to achieve production targets and quality objectives - Implement and monitor production schedules to meet customer demands - Identify areas for improvement and implement solutions to enhance plant efficiency **Qualifications Required:*...