3208 Regulatory Affairs Jobs - Page 12

About Intas: 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 over 85 countries worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare. The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the im...

We are looking for a skilled Senior Executive to lead our transport operations team in ACME SERVICES PRIVATE LIMITED. The ideal candidate will have 4 to 8 years of experience in the employment firm or recruitment services industry. Roles and Responsibility Manage and oversee daily transport operations for smooth and efficient service delivery. Coordinate with drivers, mechanics, and other stakeholders to ensure timely issue resolution. Develop and implement strategies to enhance operational efficiency and reduce costs. Monitor and analyze performance metrics to identify areas for improvement. Collaborate with the logistics team to optimize routes and schedules. Ensure compliance with regulat...

About the Company Embarking on the frontier of technological progress, Discrete Circuits Pvt. Ltd. takes pride in its commitment to pioneering innovation and delivering state-of-the-art solutions that dynamically cater to our customers' evolving needs. Our journey unfolds through a comprehensive process, beginning with extensive research, leading to meticulous development, followed by rigorous testing, seamless production, and culminating in unwavering commitment to quality control. Join us in shaping the future of electronics, where innovation and customer satisfaction guide our journey. Position Overview:- We are seeking a Regulatory Affairs Executive to manage certifications, audits, and ...

Job Purpose Compliance advisory role involves providing guidance and support to organisations on compliance matters. Compliance advisors stay up to date with legal and regulatory developments, assess their impact on the organisation, and provide recommendations to ensure compliance. Duties and Responsibilities Providing advice on all lending & deposit products to businesses Review policies/product /process notes and approve after verifying adherence to regulatory requirements. Review product journey / documentation and confirm before Go-Live. Advising management on the companys compliance with laws and regulations through detailed reports Researching industry compliance regulations and polic...

SR. Executive/Assistant Manager/Manager - Regulatory Affairs Roles and Responsibilities - To prepare dossiers as per CTD/ACTD guidelines for product registration, renewal & variation applications to submit in regulated / semi regulated countries. - To arrange administrative documents required for dossier submission & export purpose (Manufacturing Lic, WHO-GMP, P.P/COPPs/FSC- Procuring and legalization). - To check & approve the artworks for regulated / semi regulated countries. - To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission. -Handling queries pertaining to regulatory submissions from various regulatory authorities. - Maintain re...

Position Purpose Responsible for ensuring efficient processing of Trade Finance Operations of MEA branches through close coordination with branches and ISPL ; ensure smooth and optimized functioning of the activities in accordance with internal policies & guidelines and external regulations. Responsibilities Direct Responsibilities I. Ensure that the Control framework for the activities under his scope is adequate and in line with the Group and CIB policies and guidelines Manage operational risk, and ensure accurate reporting of operational risk incidents - maintain safe operational risk environment and work closely with OPC on all identified areas of risk and agreed corrective action plans....

Job Purpose This job exists to onboard vendors and manage code creation process across all businesses with specific emphasis on RBI regulatory requirements. Duties and Responsibilities ‚Ensuring completeness and accuracy of vendor related data ‚Provide data within internal / external teams for: a. RBI inspections / audits b. Internal audits of Credit Operations c. Internal audits of other departments within BFL ‚Managing a team setup at Outsourced/Inhouse location ‚Monitoring all partner onboarding channel TAT & SLAs. ‚Handle different type of queries from field team and Business. ‚Manage escalations from Businesses and other stakeholders. ‚Managing Quality performance of team. ‚Initiate mul...

We are looking for a highly skilled and experienced Associate Regulatory Affairs professional to join our team at DDReg Pharma Pvt. Ltd., located in the Pharmaceutical & Life Sciences industry. Roles and Responsibility Develop and implement regulatory strategies for pharmaceutical products. Prepare and review regulatory submissions, including clinical trial applications and marketing authorizations. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Conduct thorough reviews of regulatory documents to ensure accuracy and completeness. Maintain up-to-date knowledge of changing regulatory requirements and guidelines. Provide training and support to intern...

Position Purpose Provide a brief description of the overall purpose of the position, why this position exists and how it will contribute in achieving the teams goal. Responsibilities Direct Responsibilities Preparation of Compliance Documents for recertification 1.1 Recertify the KYC forms (Due Diligence Package) for completion, 1.2 Obtain mandatory documents and reports as per KYC requirements 1.3 Perform necessary checks (3rd parties, website, and stock exchange) to complete the recertification preparation, including checks against local and global blacklists. 1.4 Contact SBO to collect missing documents, opinions and sign off 1.5 Get KYC forms and mandatory documents validated by onshore ...

2 to 4 years of experience in Scientific or Medical Writing, and/or Quality and regulatory experience in post market surveillance. Experience with medical device, orthopedic or trauma devices preferred

Position Purpose Responsible for ensuring efficient processing of Trade Finance Operations of MEA branches through close coordination with branches and ISPL ; ensure smooth and optimized functioning of the activities in accordance with internal policies & guidelines and external regulations. Responsibilities Direct Responsibilities I. Ensure that the Control framework for the activities under his scope is adequate and in line with the Group and CIB policies and guidelines Manage operational risk, and ensure accurate reporting of operational risk incidents - maintain safe operational risk environment and work closely with OPC on all identified areas of risk and agreed corrective action plans....

Position Purpose You will integrate the DRS Global Monitoring team, a team of 6 people managed by a team leader based in France (Paris). DRS (Digital Risk Steering) support Business and facilitate internal communication to better address Cyber & IT Risk Management worldwide: Privileged contact and support for CISOs in IT risk and cyber management Global monitoring for entities and reporting collection IT Risk and Cyber management committee steering (panoramas, cyber taskforce) OPC-IT for ITG (Operational Permanent Control) Deployment of IT Risk & Cyber initiatives and tooling Steering of the ECB IT Security & IT Outsourcing OSI remediation plan The main activities of Global Monitoring (sub-t...

About Zscaler Serving thousands of enterprise customers around the world including 45% of Fortune 500 companies, Zscaler (NASDAQ: ZS) was founded in 2007 with a mission to make the cloud a safe place to do business and a more enjoyable experience for enterprise users. As the operator of the world’s largest security cloud, Zscaler accelerates digital transformation so enterprises can be more agile, efficient, resilient, and secure. The pioneering, AI-powered Zscaler Zero Trust Exchange™ platform, which is found in our SASE and SSE offerings, protects thousands of enterprise customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Named...

We are looking for a skilled Medical Writer with 5-10 years of experience to join our team in Hyderabad. The ideal candidate will have excellent writing and editing skills, with the ability to create clear, concise, and engaging content. Roles and Responsibility Develop high-quality medical content, including articles, blogs, and other written materials. Conduct research and analyze complex scientific concepts to create accurate and informative content. Collaborate with cross-functional teams to ensure consistency and quality of content. Edit and proofread content for clarity, grammar, and punctuation. Stay up-to-date with industry trends and developments in medical science and technology. P...

Join our team! Were building a world where Identity belongs to you. We are seeking a detail-oriented and proactive Payroll Analyst to join our Finance Global Capability Center (FGCC) team in Bangalore. This role is critical to supporting accurate and timely processing of payroll across Oktas international, including countries in Europe and Asia-Pacific. The ideal candidate will have a strong understanding of end-to-end payroll processes, excellent coordination skills to work with regional payroll teams, global payroll vendors and other internal stakeholders, and the ability to navigate complex compliance and statutory requirements in different geographies. Key Responsibilities Support the ti...

Planning, organizing and implementing strategies and activities required to procure regulatory approval for new and revised product lines under the guidance of more senior regulatory professionals. Required Candidate profile 5-10(k) and CE Marking; IDE, PMA (original/revision/supplements) preparation a plus Minimum 1-year experience in FDA regulated industry Working knowledge of Medical Device Regulations (FDA and EU

Description Author / update labelling documents such as EU SmPC, regional PIs. Act as the first layer of quality check for draft labelling documents. Ad hoc EU Proofing of Baseline English, QRD Formatting Review. Provide proofreading support for labelling documents against Health Authority regulations, ensuring timelines are met, the submissions are agency compliant and of quality. Formatting, technical / scientific content check, alignment to regional templates, client reference guide regular monitoring and tracking of Innovator labels. Review labels for compliance with applicable regulations and policies. Linguistic review of EU SmPC revisions and Support EU readability testing Review / QC...

Responsible for regulatory activity related to clinical section for US, ;EU, WHO, Canada, Australia, New Zealand and South Africa Markets Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines Ensure timely preparation of amendments related to bioequivalence to expedite approvals Review of BE protocol for all market including ROW market Review of bio-waiver information and clinical strategy before start of clinical study. Confirmation of reference product for EU countries for clinical study Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions Review of SmPC, PIL, Labeling for US, EU and o...

We are looking for a skilled professional with 2 to 6 years of experience to join our team as an Indian Cuisine expert. The ideal candidate will have a strong background in the culinary industry, particularly in Indian cuisine. Roles and Responsibility Develop and implement new menu ideas and recipes to enhance the authenticity of Indian cuisine. Conduct research on different types of Indian cuisine and their regional variations. Collaborate with cross-functional teams to ensure seamless service delivery. Provide exceptional customer service by understanding and addressing guests' preferences and dietary requirements. Maintain high standards of food quality, presentation, and safety. Stay up...

Develop detailed project plans including scope, objectives, timelines, and resource requirements. Collaborate with engineering teams to ensure technical requirements are clearly defined and met. Oversee the design, development. Required Candidate profile Bachelors degree in Engineering, Computer Science, Project Management, or a related field. Masters degree preferred. PMP (Project Management Professional) or equivalent certification

We are looking for a skilled Senior Restaurant Accountant to join our team at Brain Works Synergy India Pvt Ltd, with 7-10 years of experience in the field. Roles and Responsibility Manage and maintain accurate financial records and accounts. Prepare and review financial statements, including balance sheets and income statements. Develop and implement effective accounting procedures and policies. Analyze financial data to identify trends and areas for improvement. Ensure compliance with accounting standards and regulatory requirements. Supervise and guide junior accountants and staff. Job Requirements Strong knowledge of accounting principles and practices. Experience with financial software...

We are looking for a highly skilled and experienced Executive - HSEQ to join our team at GoKhana, with 1-3 years of experience in the field. Roles and Responsibility Develop and implement effective health, safety, and environmental management systems. Conduct regular audits and inspections to ensure compliance with regulatory requirements. Provide training and guidance on health, safety, and environmental procedures. Investigate incidents and accidents, and develop corrective actions plans. Collaborate with other departments to promote a culture of health, safety, and environmental awareness. Maintain accurate records and reports on health, safety, and environmental performance. Job Requirem...

As a Global Strategy Leader for a pharmaceutical portfolio, you will play a crucial role in leading the strategic direction and execution of regulatory strategies. Your responsibilities will include: - Developing global regulatory strategies for the company's pharmaceutical portfolio, such as IND/CTAs, NDAs, NDSs, MAAs, and other key regulatory submissions. - Collaborating with senior leadership in various functional areas to align regulatory strategy with overall product development and business objectives. - Providing expert guidance on regulatory requirements, market access strategies, and potential risks to inform decision-making across the organization. - Overseeing the planning, prepar...

As a global integrated pharmaceutical company, Jubilant Pharma Limited offers a wide range of products and services to customers worldwide. The company is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. **Role Overview:** You will be a part of Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma. JGL has Research & Development units in Noida and Mysore, along with manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand. **Key Responsibilities:** - Engage in the manufacturing of APIs at the USFDA approved site in Mysore, focusing on Lifestyle driven Therapeutic Areas such as CVS and CNS. - Contribute to the B2B model for EU, Canada,...

As a member of Jubilant Pharma Limited, you will be part of a global integrated pharmaceutical company that offers a wide range of products and services to customers across geographies. The company organises its business into two segments: - **Specialty Pharmaceuticals**: This segment includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. - **Generics & APIs**: This segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates two manufact...