3208 Regulatory Affairs Jobs - Page 18

Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are seeking an SME (Subject Matter Expert) in Literature to join our team and contribute to AI-driven educational content. This is a remote, flexible opportunity where you can use your expertise in literature to refine AI systems focused on literature education and content generation. Key Responsibilities:. Annotate and evaluate AI-generated Literature content, ensuring alignment with academic standards and relevant literary concepts. Provide detai...

Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . We are seeking an SME (Subject Matter Expert) in Literature to join our team and contribute to AI-driven educational content. This is a remote, flexible opportunity where you can use your expertise in literature to refine AI systems focused on literature education and content generation. Key Responsibilities:. Annotate and evaluate AI-generated Literature content, ensuring alignment with academic standards and relevant literary concepts. Provide detai...

Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . Who you are & how you can contribute. We are looking for highly skilled and detail-oriented Editor with exceptional abilities in analytics, comprehension, and consistency. If this describes you, we are excited to offer you an incredible opportunity to work remotely as a freelancer. Join us in contributing to the creation of data that powers the training of advanced AI models. Role & Responsibilities:. Help in the training of an AI assistant model to e...

Join Us as an Investment Analyst and Shape Investment Strategies!. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. Based in Hyderabad, we are a young, fast-moving team on a mission to build AI for Good, driving innovation and positive societal impact. We are seeking an Investment Analyst to analyze market trends, conduct research, and assist in developing investment strategies. You will help identify profitable investment opportunities and monitor financial markets. Key Responsibilities:. Conduct in-...

Join Us as an Investment Analyst and Shape Investment Strategies!. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. Based in Hyderabad, we are a young, fast-moving team on a mission to build AI for Good, driving innovation and positive societal impact. We are seeking an Investment Analyst to analyze market trends, conduct research, and assist in developing investment strategies. You will help identify profitable investment opportunities and monitor financial markets. Key Responsibilities:. Conduct in-...

Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . Who you are & how you can contribute. We are looking for highly skilled and detail-oriented Editor with exceptional abilities in analytics, comprehension, and consistency. If this describes you, we are excited to offer you an incredible opportunity to work remotely as a freelancer. Join us in contributing to the creation of data that powers the training of advanced AI models. Role & Responsibilities:. Help in the training of an AI assistant model to e...

Join Us as an Investment Analyst and Shape Investment Strategies!. Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. Based in Hyderabad, we are a young, fast-moving team on a mission to build AI for Good, driving innovation and positive societal impact. We are seeking an Investment Analyst to analyze market trends, conduct research, and assist in developing investment strategies. You will help identify profitable investment opportunities and monitor financial markets. Key Responsibilities:. Conduct in-...

Soul AI is a pioneering company founded by IIT Bombay and IIM Ahmedabad alumni, with a strong founding team from IITs, NITs, and BITS. We specialize in delivering high-quality human-curated data, AI-first scaled operations services, and more. . Who you are & how you can contribute. We are looking for highly skilled and detail-oriented Editor with exceptional abilities in analytics, comprehension, and consistency. If this describes you, we are excited to offer you an incredible opportunity to work remotely as a freelancer. Join us in contributing to the creation of data that powers the training of advanced AI models. Role & Responsibilities:. Help in the training of an AI assistant model to e...

We are seeking a detail-oriented and experienced Compliance Officer to oversee and enforce regulatory compliance across the organization. In this fully remote, flexible freelance role, you will play a critical role in ensuring that the company adheres to legal, ethical, and regulatory standardssafeguarding our operations and reputation. Key Responsibilities Develop, implement, and monitor compliance programs, policies, and internal controls Ensure adherence to financial regulations, industry standards, and internal governance frameworks Conduct compliance audits and risk assessments to identify and mitigate potential issues Provide training and guidance to employees on compliance-related mat...

Role Overview: You will be responsible for supporting Regulatory Affairs (RA) activities for nutraceutical products. Your primary duties will involve arranging legal documents such as POAs, LOAs, and Apostillizations, and sending hard copies to country teams. Additionally, you will be responsible for arranging admin documents (GMP, COPP & FSC) and Apostillizations, and coordinating with the HO team to send hard copies to country teams. You will also be coordinating the technical documents like Qualitative & Quantitively (Q&Q documents) with the RA team, getting them Apostilled, and sending hard copies to country teams. Key Responsibilities: - Arrange Legal Documents (POAs, LOAs) and Apostill...

Role Overview: At ZOLL, we are dedicated to improving patient outcomes and saving lives by providing innovative technologies globally. As the Manager of Operations, you will play a crucial role in organizing and overseeing the daily operations of the company to ensure efficiency and productivity. Your responsibilities will include managing procedures, coaching employees, and implementing strategies to enhance the company's operations and long-term success. Key Responsibilities: - Oversee operational departments such as Warehouse & Supply Chain, Tech Service, Regulatory Affairs, and IT - Collaborate with department managers to make decisions and set strategic goals - Supervise staff from diff...

As a global integrated pharmaceutical company, Jubilant Pharma Limited offers a wide range of products and services to customers worldwide. The business is organized into two segments: - **Specialty Pharmaceuticals**: This segment includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, Generics & APIs. - **Generics & APIs**: This segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India, along with manufacturing facilities in Mysore, Karnataka, and Roo...

Role & responsibilities Role Overview: The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory submissions (CTD/eCTD) in line with EU/UK/and other global regulatory requirements. The role requires close coordination with cross-functional teams (Formulation, Analytical, Quality, Production, and Packaging) to ensure timely and compliant dossier submissions. Responsibilities : Compile, review, and manage dossiers (Modules 1-5) for regu...

Job Summary Payroll Specialist is responsible for executing the organization's payroll activities, ensuring pay is processed on time, accurately and in compliance with government regulations. This role involves payroll, aiding in data gathering, assisting in ad hoc projects and additional payroll works when required. Job Requirements EMEA Based payroll experience is required. Payroll Processing: Work with vendor for preparation and distribution of the company's payroll, ensuring accurate and timely processing of payroll transactions including salaries, benefits, taxes, and other deductions. Compliance: Ensure compliance with as per the government legislation requirements. Stay updated on cha...

Job Title: Regulatory Affairs Manager Department: Regulatory Affairs / Quality & Compliance Reporting to: Head Regulatory Affairs Job Purpose: To lead and oversee all regulatory affairs activities, ensuring company products comply with applicable local and international regulatory requirements. The role involves developing regulatory strategies, managing submissions and approvals, and maintaining strong relationships with health authorities to support product launches and lifecycle management. Key Responsibilities: Regulatory Strategy & Compliance Develop and implement regulatory strategies for new product registrations, renewals, and variations in alignment with business objectives. Ensure ...

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

Role Overview: As the Medical Safety Lead at Sandoz, you will be responsible for owning the safety strategy of assigned products and ensuring ongoing evaluation of the overall safety profile. You will serve as the medical safety representative for various safety documents and assessments, including Risk Management Plans, Periodic Safety Update Reports, and medical risk assessments. Additionally, you will collaborate with internal and external stakeholders to support safety-related activities and submissions. Key Responsibilities: - Own the safety strategy of assigned products and evaluate the overall safety profile - Serve as the medical safety representative for Risk Management Plans, Perio...

As a Clinical Product Owner/Scientist in Bangalore with over 10 years of experience, your role involves leading new product development initiatives in Healthcare and Life Sciences. You will collaborate with medical practitioners, OEM partners, and cross-functional engineering teams to drive innovation, solution development, and strategic growth initiatives. Key Responsibilities: - Define clinical use cases, workflows, and user requirements for medical devices. - Identify and validate the needs for new medical devices and enhance existing devices through research and collaboration with medical experts. - Conduct market research and competitive analysis to shape customer market entry strategie...

Hello Connections, We have immediate openings for the following positions. Open Positions in theQARA-DQARole Greetings from Tekaccel! Job Title:QARA-DQA Experience: 5+ years Location:Gurgaon Work mode: WFO NP: 0-30 Days Hire type: Full-time Key Responsibilities: Be a part of the sustaining project team and work in the design quality engineering across the entire product cycle. Ensure appropriate project/sustaining quality deliverables are created and properly executed (e.g., project design & development plan, risk management plan, hazard analysis, use and design FMEA, field assessment plan, and software validation plan if applicable). Working on product DHF, design input, design output, prod...

As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include: - Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market - Performing Gap Analysis and Remediation for module 3 -CMC - Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN - Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guideline...

As a part of Jubilant Pharma Limited, you will be joining a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The company is organized into two key segments: - **Specialty Pharmaceuticals:** This segment includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. - **Jubilant Generics (JGL):** JGL, a wholly-owned subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in...

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 various geographies. The company organizes its business into two main segments: - **Specialty Pharmaceuticals**: This segment includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. - **Generics & APIs**: This segment focuses on Solid Dosage Formulations & Active Pharmaceutical Ingredients. **Key Responsibilities**: - Play a crucial role in...

Need Sr. RA Executive for a Reputed Pharmaceutical Company at Ahmedabad. Jobless Candidate with positive mindset to join immediately will be preferred. Notice period allowed is maximum 30 days. Apply of WhatsApp at 9879604156

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products