11 Ema Regulations Jobs

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment. If someone asks for payment on our behalf, it is a scam. Please report the incident to the local police or cybercrime unit. Your trust and safety are important to us. Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations. The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world. Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, ...

As an Associate Director, Established Brands Regulatory Lead at Bristol Myers Squibb, you will play a crucial role in overseeing the lifecycle of marketed products within the Established Brands portfolio. Your responsibilities will include: - Leading the regulatory strategy for assigned Established Brands assets to maintain marketing authorizations globally - Representing GRS at the Established Brands Global Program Team (GPT) and collaborating with regional and country regulatory leads - Supporting portfolio optimization by identifying regulatory risks, managing response strategies, and ensuring compliance with regulatory requirements - Reviewing Clinical Study Reports, providing content to...

As a Senior Manager of Benefit Risk Assessment Operations at Bristol Myers Squibb, you will be responsible for collaboratively authoring and revising key drug safety-focused documents to support upcoming submission documents to Regulatory Health Authorities worldwide. Your role will involve working closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information for the development of new treatments and post-marketing safety activities. **Principal Responsibilities:** - Attend meetings related to structured benefit risk assessment (SBRA) to understand approaches and contribute to discussions. - Schedule and facilitate meetings to discuss risk manag...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

JOIN AMGEN'S MISSION OF SERVING PATIENTS At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborati...

As a Quality Management System (QMS) Specialist, your role will involve establishing, implementing, and continuously improving the company's QMS to support its clinical-stage biopharmaceutical development programs while ensuring compliance with regulatory requirements such as FDA, EMA, ICH, and GxP standards like GMP, GDP, GCP, GLP. Your responsibilities will include: - **QMS Development & Implementation**: - Developing, implementing, and maintaining a phase-appropriate QMS aligned with regulatory requirements. - Establishing, reviewing, and updating Quality System documentation to support GxP operations. - Serving as the system owner for the electronic QMS and ensuring effective document co...

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission Preparation of respective CTD sections and submission of final query response to agency Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval To upload documents in national portal for respective European regulatory agency Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation Review of the mockups for all regulatory submissions and commercial supplies Maintenance of internal database Co-ordination with consulta...

Job Title: Clinical Quality Compliance Manager Location: Bengaluru, Karnataka, India Reports To: QA/Compliance Director or Clinical Operations Director Job Summary: Clinical Site Auditor to ensure compliance and quality at Clinical Trial sites. You will conduct site audits, review documentation, and verify adherence to protocols, GCP, GLP and regulatory requirements. Key Responsibilities: Conduct audits of clinical research sites across phases IIV. Review CRFs, informed consent forms, and regulatory documents. Identify and report audit findings; recommend corrective actions. Support site staff with compliance guidance and training. Prepare audit reports and follow up on CAPA implementation. ...

As a Regulatory Administrator at our company, you will play a vital role in providing administrative and operational support to the Regulatory Affairs department to ensure the smooth facilitation of the regulatory submissions process. Your responsibilities will include: - Uploading, organizing, and maintaining regulatory documents within various regulatory authority submissions portals such as CTIS, FDA eGateway, and CESP. - Coordinating the redaction of confidential information in regulatory documents and ensuring compliance with global standards. - Collaborating with external vendors for document redaction services and monitoring the progress of redaction processes. - Assisting in preparin...

The Senior Regulatory Administrator (SRA) role is crucial in providing vital administration and operational support to the Regulatory Affairs department. As an SRA, your primary responsibility is to ensure the efficient management and upkeep of regulatory documents within the regulatory systems. Your pivotal role involves overseeing the accuracy, compliance, and timely submission of regulatory documentation to regulatory bodies such as the FDA, EMA, and other international authorities. Your duties will include managing the organization of regulatory documents for submissions, ensuring adherence to relevant guidelines and regulations, optimizing processes, mentoring team members, and fosterin...

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to heal...