2122 Regulatory Affairs Jobs - Page 30

KPMG India is looking for Executive - Adobe QA to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing exis...

We are Reckitt Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Research & Development In Research and Development, were full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, o...

We are Reckitt Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege. Research & Development In Research and Development, were full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, o...

Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle ...

Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ ...

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Navi Mumbai, India, 400706 Who we are The opportunity The Director, Regulatory Affairs Post-Approval (US Generics) is a senior regulatory leader responsible for independently setting the strategic direction and ensuring the successful execution of all post-approval regulatory activities for U. S. FDA-regulated generic drug products. This role provides regulatory leadership across the organization, ensuring compliance with FDA regulations and guidances, while driving continuous improvement in lifecycle management processes. The Director leads a team of regulatory professionals and serves as a key l...

The candidate must possess in-depth functional knowledge of the process area and apply it to operational scenarios to provide effective solutions. The candidate must be able to identify discrepancies and propose optimal solutions by using a logical, systematic, and sequential methodology. It is vital to be open-minded towards inputs and views from team members and to effectively lead, control, and motivate groups towards company objects. Additionally, the candidate must be self-directed, proactive, and seize every opportunity to meet internal and external customer needs and achieve customer satisfaction by effectively auditing processes, implementing best practices and process improvements, ...

We are looking for a young and talented individual to market our specialized products within the travel agents network in Maharashtra & Gujarat People with prior experience within the travel industry , specifically looking into channel sales will be preferred The job will require traveling within Mumbai & the states of Maharashtra & Gujarat Our Major Products will include Ladakh tours for the Summer along with Europe & Sri Lanka tour products

Incoda Media is looking for Assistance Manager / Manager - Media Sales to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully a...

Role & responsibilities To ensure API regulatory activities are as per stipulated time schedule and timely readiness of API regulatory documents / DMFs for new submissions / updates. To provide the necessary regulatory support/ advice/ guidance to the concerned API Manufacturing sites/ R & T Unit. To assure the quality of DMF, its submission and maintenance of submitted DMFs and updation on DMFs taking into consideration company Intermediates business. To co- ordinate and collaborate with QA/ QC/ Production/ Development department Preferred candidate profile M.Sc. Organic / Analytical Chemistry Full time with 15-25 years experience

Key Responsibilities 1. Executive Support Manage and prioritize the executives calendar, ensuring optimal use of time across time zones Schedule internal and external meetings, organize travel logistics, and coordinate accommodations Handle email, phone, and other communications with discretion and professionalism Prepare executive-level presentations, reports, and documentation for business reviews and leadership meetings Manage expense reports and provide end-to-end administrative support 2. Special / Strategic Project Support Assist in driving special projects, ensuring timelines and deliverables are metTrack project milestones, identify bottlenecks, and coordinate with stakeholders for t...

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

As a global integrated pharmaceutical company, Jubilant Pharma Limited offers a diverse range of products and services to customers worldwide. The business is structured into two main segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a subsidiary of Jubilant Pharma, has Research & Development units in Noida and Mysore, India, along with manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand. The Mysore facility, spread across 69 acres, is a USFDA approved site primarily focused on manufacturing APIs for Lifestyle driven Therapeutic Areas such as CVS and CNS. The Roorkee facility is a state-of-the-art site approved by multiple regulatory bodies...

An exciting opportunity has arisen at Centre of Excellence in Bengaluru, India for the position of Quality Assurance Officer. As the Quality Assurance Officer for Centre of Excellence (CoE), you will be responsible for implementing, maintaining, and enhancing the quality management system for various programs. Your role will involve administrative, analytical, and technical tasks to assist the CoE team in formulating teams, assigning responsibilities, and evaluating performance. You will work closely with various departments within the organization, including quality assurance, regulatory affairs, and operations, to maintain compliance and support continual improvement. The ideal candidate f...

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is structured into two main segments: Specialty Pharmaceuticals and Generics & APIs. Within Specialty Pharmaceuticals, Jubilant Pharma focuses on Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. In addition, the company is involved in Generics & APIs, including Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL), a subsidiary of Jubilant Pharma, operates in India with Research & Development units located in Noida and Mysore. JGL has two manuf...

As a Quality Management professional, you will be responsible for developing and implementing a comprehensive Quality Management System (QMS) for the ingot production process. This involves aligning the system with industry standards and best practices, as well as establishing quality control procedures, guidelines, and protocols for all stages of ingot manufacturing. Leading the quality control team, you will oversee inspections and tests on raw materials, in-process products, and finished ingots. Your role will also involve ensuring compliance with quality specifications and customer requirements through the implementation of inspection processes. Regular audits and evaluations will be con...

Role & responsibilities We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier...

US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications,PMA,supplements or De Novo requests (if applicable),Support establishment registration Medical device listing, Ensure compliance with 21 CFR Part 820 (QSR) and UDI Office cab/shuttle Annual bonus Health insurance Provident fund

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

About Apotex Inc. Job Summary Responsible for leading Regulatory Affairs individuals accountable for management of life cycle changes including change assessments and submissions all the way to approvals of PLCM (Product Life Cycle Management) projects to support regulatory compliance continued supply of Apotex products. Also responsible for Global Regulatory practices to manage regulatory information in various databases and ensure consistent practices and compliance is maintained at Global Apotex sites. This is to be accomplished by planning and managing the activities of the group. Strong linkages need to be established with R&D, Quality, Operations and the Regulatory Market Affiliates/cu...

Job Overview Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle ...

Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects. Essential Functions Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff; Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate; Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ ...

Job Summary : Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations : a. Prepare and review variation...

We are looking for a skilled Senior Process Manager to join our team at eClerx Services Ltd., an IT Services & Consulting company. The ideal candidate will have 7-10 years of experience in process management and a strong background in managing complex processes. Roles and Responsibility Manage and oversee the development, implementation, and improvement of business processes. Analyze and identify areas for process improvement and implement changes to increase efficiency and productivity. Collaborate with cross-functional teams to ensure seamless execution of processes. Develop and maintain process documentation and standards. Ensure compliance with regulatory requirements and industry standa...

Consultancy of the year in the British Bank Award and has been ranked Top 100 Best Companies for Women in India 2022 by Avtar & Seramount . With our presence across 32 cities across globe, we support 100+ clients acrossbanking, financial and Energy sectors. We are recognized for our deep transformation execution and delivery. WHY JOIN CAPCO You will work on engaging projects with the largest international and local banks, insurance companies, payment service providers and other key players in the industry. The projects that will transform the financial services industry. MAKE AN IMPACT Innovative thinking, delivery excellence and thought leadership to help our clients transform their busines...