933 Usfda Jobs - Page 21

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in No walk-in interviews on 27-Aug-25

Key Responsibilities: Warehouse Operations Leadership: Direct and supervise daily warehouse activities, including receiving, storage, material handling, dispatch, and documentation. Ensure that all operations align with company policies, cGMP (current Good Manufacturing Practices), and regulatory standards. Inventory Management: Oversee inventory control systems to maintain accurate stock levels, prevent shortages or overstock situations, and facilitate timely replenishment and movement of materials. Implement cycle counts, reconciliation, and develop strategies to minimize inventory discrepancies. Compliance and Documentation: Ensure all warehouse processes adhere to regulatory guidelines, ...

Were Hiring: Sr. Business Development Manager NPI (Domestic Market) ? ???? Location: India ???? Qualification: B.Pharm / M.Pharm + MBA (Top B-School preferred) ???? Experience: 1014 years | Domain: Bio-similars / Oncology Therapy This is a strategic leadership role split between Business Development (50%) and New Product Innovation (50%) . The right candidate will drive portfolio growth, partnerships, and new product strategy while collaborating closely with R&D, regulatory, supply chain, and commercial teams. Key Responsibilities: ? Identify & evaluate new molecules, NDDS & value engineering opportunities ? Lead end-to-end launch process, ensuring timely delivery & compliance ? Conduct comp...

Experienced QA person managing multiple projects involving implementation. Ensuring set norms & laws are met. Excellent knowledge of QA processes of risk management, clinical data management, electronic data management.

About this role: Wells Fargo is seeking a Senior Quality Assurance Administrator. In this role, you will: Provide support and scoring guidance quality assurance staff by answering questions on regulations or compliance, procedures, policies and First Call Resolution Escalate key maintenance errors identified during scoring process and ensure resolution of same, reviewing programs, processes, documentation, to ensure compliance with internal company requirements or government regulations Review systems to ensure company standards are met, exceptions are notated, and issues escalated as necessary Assist in development and design of product specific databases Review and score work Prepare calib...

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 ...

Hiring For QC AM For Formulation Co in Khambhat Location Qualification: BSc / MSc / B.Ph / M.Pharm Exp : 8 to 18 Years CTC: Good Salary Experience in Formulation Is Must Send CV on sdpbharuch@gmail.com with Subject: QC Khambhat Share with Friends Required Candidate profile SDP HR SOLUTION 611, Golden Square, Beside DMART, Near ABC Circle, Bholav, Bharuch - 392001 Free Jobs !!1 Share with Your Friends & Colleagues!!!

We are seeking a dynamic and experienced candidate to lead and manage the overall operations of our sterile injectable manufacturing plant. The ideal candidate will be responsible for ensuring seamless plant operations, regulatory compliance, quality standards, and people management while driving productivity and efficiency. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous impr...

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and document...

Role & responsibilities Coordination with different departments vise (QC, Manufacturing & QA) for material testing. Issuance and release as per the plan. Planning and reviewing of work force availability for material receipts, movements, sampling, Labeling, relocation & dispensing activities. Reviewing online documentation from all the areas. Initiating the material write- offs for the rejected as well as non-moving slow moving & expired materials with proper management approval and customs approvals and disposal as per SOPs. Coordinating with production Head and production planning department to execute daily production schedule requirements. Monitoring systems / team to follow as per the G...

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India 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 at ...

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years Language - Ability: English(International) - Intermediate 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...

The Apex Group was established in Bermuda in 2003 and is now one of the worlds largest fund administration and middle office solutions providers. Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion. Thats why, at Apex Group, we will do more than simply empower you. We will work to supercharge your unique skills and experience. Take t...

Job Title: QMS Manager Business Unit: Global Quality Compliance Job Grade G10 / Manager 1 Location : Mohali Educational Qualification: M.Sc / B.Pharm / M.Pharm Experience: 12+ yrs Quality Management System 1. Implement, operate, monitor and maintain Quality Systems which enable operations on site to occur in an efficient manner and in compliance with Global Quality Standards and cGMPs. 2. Review and Archival of Quality System documents. 3. Follow up for timely closure of Quality Management System documents. 4. Participating in the investigation analysis for Complaints and Audit finding, moreover responsible for providing batch disposition decision as per the outcome of PQC investigation. 5. ...

Job description for Asst. Manager/Sr. Executive - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Develops and implements submission strategies for PIND, 505(b)(2); NDAs; ANDA. 2. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2; ANDA submissions including FDA meeting requests and packages. 3. Critically reviews and approves documentation from clinical development, non-clinical development, iPSP, Research and Development (R&D), Quality, Technical Operations, Lab...

Job description for Executive / Officer - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Compilation of various applications like CC / CGT / iPSP / PIND packages. 2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages. 3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications. 4. Review and compilation of DMF sections for NDA/ANDA/PAS filing. 5. Ensures that project timelines are develop...

We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, a...

Title: QA Manager Business Unit: CQC (Complaints) Job Grade: G11A / Manager 2 Location : Tandalja, Vadodara Educational Qualification: B.Pharma / M.Sc (Life Sciences) Experience: 10 to 14 Years Position Summary Review of Product Quality Complaint Investigation Reports (Drug Products). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls & Product Quality Complaint closure etc. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received Product Quality Complaint. Note: 1) Candida...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! The candidate will be an integral part of the AskHR team, a high-touch and customer-focused function within BMC HR. The candidate is expected to deliver an exemplary employee experience with every interaction. Candidates needs to be approachable, customer focused, flexible, action-oriented, and innovative along with great verbal and written communication skills. They should have great attention to detail while supporting a broad range of HR activities including data management, benefits administration, offboarding and...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

Yes, I understand the job description completely. Here is a summary of my understanding: Role: Regulatory Affairs Manager Level: Mid to Senior Location: Gurgaon, India (with a hybrid work model) Salary 6-9 LA The Core Purpose of the Role: We are looking for a regulatory expert to ensure their productsspecifically food, nutraceuticals, and agricultural inputs (like fertilizers)are legally compliant in India and for export markets, with a focus on the U.S. and EU. This person will be the central point of contact for all regulatory matters, both internally and with external authorities. Key Responsibilities Breakdown: Compliance Management: Manage all regulatory requirements for the company's d...

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization an...

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry. Job Title: Director /VP (Regulatory Affairs) Location: Gurgaon Reports To: CEO About the Role We are seeking a highly skilled Regulatory Affairs Specialist to support global regulatory activities for our advanced Medical Devices/Equipments . This role plays a key part in developing regulatory strategies, managing submissions, and ensuring ongoing compliance for Class II and III medical devices. The successful candidate will have experience working with global health authorities, especially the US FDA , and a deep understanding of the regulatory landscape for complex medical tec...

General Summary: The Technical Support Specialist II is responsible for assisting our partners in diagnosing and resolving a partners product issues or questions. This role works in partnership with cross-functional teams to troubleshoot, resolve, and document issues, getting partners back on track to having a positive experience with our products. Essential Duties & Responsibilities: Provides support to cross-functional teams, with a high attention to detail Researches, analyzes, and documents findings May influence others within the Technical Support team through the explanation of facts, policies, and practices Interacts with partners to provide technical support via email, phone, chat, c...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...