2122 Regulatory Affairs Jobs - Page 20

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & Medical device Rules 2017. 3. Demonstrated success in a start-up, entrepreneurial work environment 4. Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries 2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.

JOB DESCRIPTION: Job description: Lead a high preforming team of Submission publishers Responsible for delivering and driving high quality submissions by self and the team in compliance with technical requirements from regulatory authorities. Responsible for fixing/guiding the team to fix/resolve any errors/challenges/roadblocks to ensure quality output to the HA - Submissions troubleshooting Drive first time right approach by educating the team and upstream workstreams on the relevant activities Collaborate with other Operations team/other relevant stakeholders to work towards a common goal and drive and deliver quality outputs Work closely with the team to Identify value adds/process impro...

As a Pharma Regulatory Affairs Officer at Syngene, you will play a crucial role in executing submissions for various licensing activities and ensuring timely approvals from regulators. Your responsibilities will include preparing and submitting applications to CDSCO, responding to regulators" queries, following up for approvals, and maintaining compliance with regulatory standards. You will be expected to collaborate with internal and external stakeholders, maintain records of submissions and approvals, liaise with State regulators for manufacturing licenses and permissions, and provide consultation to internal stakeholders and clients on national regulatory requirements. In addition, you wi...

As a Production Chemist specializing in the formulation and production of nutraceutical and Aayush products, your primary responsibility will be to develop and optimize formulations for various dosage forms such as tablets, capsules, and liquid forms. You will be involved in conducting scale-up studies from lab to production scale while ensuring compliance with regulatory standards. It will be essential for you to prepare and manage comprehensive bill of materials for all products, ensuring accurate documentation of raw materials, quantities, and suppliers. Your role will also involve overseeing the production process, ensuring adherence to predefined quality standards and production timelin...

About The Role As a Senior IT Business Analyst, you work closely with software engineers on building and enhancing IT solutions which move functionalities to the new technical framework This includes specifications, architecture decisions and testing It requires collaboration with an international user community as well as a wide range of other IT colleagues across the globe, Key Responsibilities Drive building new business application functions Collect and translate business and technical requirements to developers including testing support Contribute to architecture decisions in new technical landscape and analyze dependencies on other teams Build up and share knowledge about applications ...

Manager - Government Liaisoning FMCG at Ahmedabad The person should be responsible for building and maintaining relationships with government officials and regulatory bodies, ensuring the company's compliance with relevant laws and regulations, and advocating for the company's interests at the local and state levels. This role requires strong communication, negotiation, and relationship-building skills, as well as a deep understanding of the FMCG industry and its regulatory landscape. Networking with key government people in NAPL (Naroda), Factory experience, GIDC, Pollution control board, PF, ESIC Labour connections, FRRO, Fssai- food department, water waste. need person who has genuine net...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing Years of Experience: 0 to 1 years 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.accent...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years 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 do You will be aligned with our Life Scienc...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years 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 do Embedding digital transformation in healthcare operati...

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensu...

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 timely and accurate payroll inputs processing and initial validation f...

We are not looking for someone who checks every single box - were looking for lifelong learners and people who can make us better with their unique experiences. 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 oth...

Role & responsibilities To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all LATAM, MENA, CIS and ROW Countries and other country as per company requirements. Responsible for final review of dossier before submission. To coordinate with technical team for documents required for dossier. Responsible to gather data related for dossier through online sources, laboratories, manufactures, etc. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in acco...

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software...

Principal Accountabilities Accountability Supporting Actions Government Affairs Liaising with the state machinery like Secretariat, Govt officials, bureaucracy, and other govt. bodies like labor Department, municipality, Police authorities etc. Regulatory Affairs Focus on interpretation of new laws. Monitor and analyze legislative and regulatory issues that may impact the organization. Engage with government officials and industry associations to advocate for the company's interests. Policy Advocacy Play a critical role in advancing the organization's objectives by developing and implementing strategies to influence public policy. Work closely with internal teams, external stakeholders, and ...

Key Responsibilities: • Responsible for Creating Labeling Strategy for the health authority interactions and handling HA or Country Organization (CO) labeling queries for assigned program/ products. • Ensure Artwork Management for Initial Submission / Commercial Launch activities in coordination with CFT team. • Responsible for Promotional Material Review and participate in CFT meetings representing Regulatory on strategic decisions by ensuring no misleading information. • Responsible to Coordinate with External Vendor to ensure Translations documents are prepared / reviewed to support Global Regulatory Submissions. • Responsible for SPL Preparation for Initial Submission / Labelling Respons...

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

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

Key Responsibilities Working under the direction of the Manager of Product Safety, serve as Product Safety Engineer supporting key Business Units and customers in India. Assist with other businesses or Enterprise-wide initiatives as requested by the Senior Director, Product Safety. Develop a deep understanding of global operations and requirements to effectively assist Business Unit functional owners with programmatic roll-out, integration and implementation. Apply technical expertise in one or more engineering disciplines, including chemical, mechanical and electrical. Leverage safety knowledge and experiences within the engineering disciplines. Serve in a consultative capacity with Busines...

You will be joining Jubilant Pharma Limited, a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is structured into two key segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India. It operates manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing respectively. The Mysore facility, spread across 69 acres, is a USFDA approved site that manufactures APIs targeting Lifestyle driven Therapeutic Areas such as CVS and CNS. It is a market lead...

As a Regulatory Manager, Delivery, CMC Small Molecules Mature Products at GSK, you will play a pivotal role in leading a team dedicated to ensuring the continuous supply of essential medicines through the delivery of high-quality regulatory dossiers. Your contributions will directly impact patient care on a global scale, offering you the opportunity to collaborate with a diverse range of stakeholders, drive process enhancements, and uphold regulatory excellence. If you are proactive, detail-oriented, and enthusiastic about leadership in the realm of regulatory affairs, this position is tailored for you. Your primary responsibilities will encompass leading and nurturing your team to cultivate...

The Manager of Regulatory Affairs, Labeling at Teva Pharmaceuticals is responsible for supervising, critically reviewing, and approving established US Gx labeling documents filed under an ANDA/505(b)(2) by team members in the US and Mumbai/Bangalore locations. The Manager must ensure compliance with federal regulations, internal processes, and company goals while meeting established timelines. Additionally, they will oversee team databases and trackers, updating them as needed. The ideal candidate should have a strong understanding of FDA US labeling regulations and guidances for products filed under an ANDA/505(b)(2) and be a Subject Matter Expert in US labeling, including SPL, PADERs, and ...

SUMMARY Job Title: Healthcare Administration Services Representative Location : Airoli, On-site Shift Timing : 5:30 PM - 3:00 AM We are in search of individuals with exceptional communication abilities and the flexibility to work different shifts to become part of our team as Healthcare Administration Services Representatives. As a part of this role, you will have a significant impact on integrating digital advancements into healthcare operations to ensure the provision of efficient and effective services. Responsibilities : Collaborate closely with the Healthcare Management team to supervise the administration of various healthcare facilities Oversee day-to-day operations, department activi...

: Job titleBond Analytics Analyst Location:Mumbai, India Corporate title Associate Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS) With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team...