3222 Regulatory Affairs Jobs - Page 41

Roles and Responsibility Collaborate with cross-functional teams to design and implement clinical research studies. Provide medical expertise and guidance on study protocols, informed consent forms, and case report forms. Develop and maintain relationships with investigators, site staff, and other stakeholders. Review and approve study-related documents, including protocols, informed consent forms, and case report forms. Ensure compliance with regulatory requirements and company policies. Participate in project team meetings and provide input on study progress and risks. Job Requirements Minimum experience in clinical research or a related field. Strong knowledge of clinical trial conduct, p...

Roles and Responsibility Coordinate regulatory submissions with cross-functional teams to ensure timely and accurate delivery. Develop and maintain relationships with regulatory authorities and stakeholders. Prepare and review regulatory documents, including applications, reports, and other submissions. Ensure compliance with regulatory requirements and guidelines. Collaborate with internal teams to resolve issues related to regulatory submissions. Maintain accurate records of regulatory submissions and interactions. Job Requirements Minimum 2 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and guidelines. Excellent communication ...

Roles and Responsibility Conduct thorough medical device safety assessments and evaluations. Develop and implement effective safety protocols and procedures. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze data and trends to identify potential risks and hazards. Provide expert guidance on medical device safety best practices. Stay updated with industry developments and emerging technologies. Job Requirements Strong knowledge of medical devices and their safety regulations. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment. Strong communication and interpersonal skills. Experience with sa...

Roles and Responsibility Develop and implement regulatory compliance programs to ensure adherence to industry standards. Conduct risk assessments and audits to identify areas for improvement. Collaborate with cross-functional teams to ensure seamless execution of regulatory requirements. Publish regulatory documents and reports as required by relevant authorities. Stay updated on changes in regulatory requirements and guidelines. Provide training and support to employees on regulatory compliance matters. Job Requirements Strong knowledge of regulatory compliance principles and practices. Excellent communication and publication skills. Ability to work independently and collaboratively within ...

Roles and Responsibility Publish and submit regulatory documents to relevant authorities. Ensure compliance with regulatory requirements and guidelines. Coordinate with cross-functional teams to prepare and review regulatory submissions. Maintain accurate records of regulatory submissions and correspondence. Stay updated with changes in regulatory requirements and implement updates accordingly. Collaborate with internal stakeholders to ensure timely submission of regulatory documents. Job Requirements Minimum 3 years of experience in regulatory submissions or a related field. Strong knowledge of regulatory requirements and guidelines. Excellent communication and coordination skills. Ability ...

Roles and Responsibility Publish regulatory submissions with high accuracy and attention to detail. Collaborate with cross-functional teams to ensure timely and successful submission of regulatory documents. Develop and maintain knowledge of changing regulations and guidelines. Review and edit regulatory documents for compliance with industry standards. Coordinate with internal stakeholders to gather necessary information for regulatory submissions. Ensure all regulatory submissions meet required quality standards. Job Requirements Strong understanding of regulatory requirements and guidelines. Excellent publishing and editing skills. Ability to work independently and as part of a team. Stro...

Roles and Responsibility Manage and publish regulatory submissions, ensuring compliance with relevant laws and regulations. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Develop and maintain relationships with regulatory authorities and other stakeholders. Stay updated on changes in regulatory requirements and implement necessary updates. Ensure accurate and high-quality content in all regulatory submissions. Collaborate with internal teams to resolve issues related to regulatory submissions. Job Requirements Strong knowledge of regulatory requirements and guidelines. Excellent communication and interpersonal skills. Ability to work independently...

Key Responsibilities: Manage the entire slot game production lifecycle from concept to launch and post-launch support Coordinate with designers, developers, artists, animators, sound designers, and QA teams Develop and maintain project schedules, budgets, and resource plans Communicate project status, risks, and milestones to stakeholders and senior management Ensure all slot games comply with industry standards and regulatory requirements Drive team collaboration and maintain a productive work environment Identify and implement process improvements to enhance efficiency and quality Support marketing and business development teams with launch strategies and promotional activities Mandatory K...

Key Responsibilities: Manage the entire slot game production lifecycle from concept to launch and post-launch support Coordinate with designers, developers, artists, animators, sound designers, and QA teams Develop and maintain project schedules, budgets, and resource plans Communicate project status, risks, and milestones to stakeholders and senior management Ensure all slot games comply with industry standards and regulatory requirements Drive team collaboration and maintain a productive work environment Identify and implement process improvements to enhance efficiency and quality Support marketing and business development teams with launch strategies and promotional activities. Mandatory ...

We are looking for a highly skilled and experienced Finance Compliance Manager to join our team at Sheraton Grand Bengaluru. The ideal candidate will have 1-3 years of experience in finance compliance. Roles and Responsibility Manage and oversee financial compliance with regulatory requirements. Develop and implement effective compliance programs to mitigate risks. Conduct audits and reviews to ensure adherence to financial regulations. Collaborate with cross-functional teams to identify and resolve compliance issues. Provide training and guidance on compliance matters to staff members. Monitor and report on compliance performance metrics. Job Requirements Strong knowledge of financial regul...

You are being sought after to take on the role of Regulatory Affairs Lead/ Project Manager, joining a dynamic team that values passionate regulatory professionals. Your main responsibilities will include managing regulatory projects for Pharmaceuticals, Biologics, Medical Devices, and other products in Global Markets. You will be expected to plan and prepare regulatory project plans/submission strategies, lead regulatory submissions, manage interactions with Health Authorities across multiple regions, and provide clear guidance to cross-functional teams by identifying regulatory gaps and assessing risks. Additionally, you will work closely with Regional Regulatory Experts, act as the primary...

Job Description: Freyr is building a next-gen Regulatory Intelligence (RI) product powered by AI/ML and automation . We're looking for a Regulatory Intelligence Lead to drive high-quality data processes, manage RI surveillance, and lead a team working across global markets in Pharma, Medical Devices, and Consumer Products . Key Responsibilities: Manage RI data surveillance , quality checks , and regulatory insights across global markets Lead a team and ensure timely, accurate delivery of regulatory updates Resolve regulatory queries and support client-specific project needs Upload and manage data on digital platforms; suggest process improvements Maintain dashboards for real-time data tracki...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications are optimize...

Description Regulatory Consultant (CMC/ EU Market Exp) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem so...

Description Medical Writer I (CTD/CTT) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovatin...

Job Description: Amgen is a leading human therapeutics company in the biotechnology industry For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

The candidate will undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion of the training, they will be placed for full-time patent analysis in the pharmaceutical domain. Required Candidate profile Scientific and Analytical Thinking Eager to work in drugs and formulation Candidates must have sound knowledge about the subjects they study in Graduation

Purpose The role has overall responsibility for Vaccines portfolio related activities in Regulatory Affairs including interactions with regulatory authorities, government bodies, industry associations and other internal/external stakeholders Main Accountabilities Regulatory ownership with necessary business acumen to support the vaccines business unit (BU) in India, Nepal and Sri Lanka Develop and ensure implementation of strategic regulatory pathways for Sanofi products in terms of market authorizations to enable faster to market Liaison with internal regulatory team such as Global Regulatory to support business continuity related to submissions/approvals for renewals, post approval changes...

Your role and responsibilities Play key role in Project Controlling, financial analysis, closing activities including audits, reporting of the division and support project management team in all financial and commercial matters and actively drive the projects performance. The work model for the role is: #Li - Onsite This role is contributing to Motion Traction Division in Bangalore/Vadodara. You will be mainly accountable for: Supports the tender manager and Project Manager on financial aspects. Provides input to negotiations on commercial issues. Provides input in local risk review process. Provides input to the Project Execution Plan on financial aspects. Prepares project invoices, financi...

The candidate will undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion of the training, they will be placed for full-time patent analysis in the pharmaceutical domain. Required Candidate profile Scientific and Analytical Thinking Eager to work in drugs and formulation Candidates must have sound knowledge about the subjects they study in Graduation

Roles and Responsibility Manage and oversee the day-to-day activities of the SOC team. Develop and implement effective security protocols and procedures to prevent cyber threats. Conduct regular risk assessments and vulnerability testing to identify potential weaknesses. Collaborate with cross-functional teams to develop and implement incident response plans. Monitor and analyze security event logs to detect anomalies and suspicious activity. Provide training and guidance to SOC team members on security best practices. Job Requirements Minimum 7 years of experience in a similar role, preferably in banking or financial services. Strong knowledge of security operations center (SOC) principles ...

Job Summary: The MES Lifecycle Manager drives the strategic planning and execution of MES installations, updates and migrations across Sanofi's industrial network and the lifecycle planning in alignment with the Product Owner Vision & product Roadmap. This role provides technical and strategic leadership in developing and implementing long-term strategies to optimize MES performance, reduce obsolescence, and align MES capabilities with Sanofi's digital transformation goals. Main Responsibilities: Strategic MES Lifecycle Management: Develop and execute a comprehensive MES lifecycle planning/ strategy aligned with Sanofi's digital transformation objectives, Product Owner Vision & product Roadm...

Main responsibilities: Provision of strategic advice to the businesses with regards to regulatory compliance linked to substances (e.g. safety data sheets, classification, packaging & labelling, transport classification, local regulations). This includes monitoring of regulations. Act with efficiency with the Global Product Stewardship team. Edit and maintain Safety Data Sheets using our IT tools. Independent evaluation and validation of substance data for classification and labelling according to international regulations e.g., GHS/CLP, Seveso, and transport regulations. Documents all product stewardship information including references, reports to track and to justify any modification in t...