933 Usfda Jobs - Page 23

Long Description The person should have knowledge in Manufacturing equipments. He should have exposure in equipment’s such as FBE,Fette/KORSCH M/C & auto coater M/C. He should be able to handle equipment trouble shoot in Manufacturing department. He should have exposure in regulatory organization . He must have faced the USFDA ,MHRA & other regulatory audits. He should have the exposure in Caliber QAMS, elog, track wise ,SAP ,WIND ,CDAS & other software. He should have the exposure in process simplification/optimization ,SABA ,elog & SCADA. Competencies Education Graduation in Pharmacy Work Experience 3-6 years of experience in Fette compression machine

Job Description We are hiring a Senior Regulatory Affairs Executive with around 5 years of experience in regulatory submissions for international markets, especially USFDA and EDQM . This role involves end-to-end regulatory dossier preparation and submission, technical data coordination, and maintaining compliance with global regulatory standards in an API manufacturing environment. Key Responsibilities Prepare, compile, and submit regulatory dossiers (DMFs, CEPs, ASMFs) to international authorities, focusing on EDQM and USFDA. Coordinate cross-functionally with R&D, QA, QC, and Production teams for document and data collection. Maintain submission timelines and follow-up systems for timely ...

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

Purchase Manager / Sr. Manager (Pharmaceutical API Manufacturing) Posted: July 2025 Drive end to end strategic procurement for a multi regulator approved API manufacturer own raw materials, solvents, intermediates, packaging, capex, and vendor development while ensuring cGMP/ICH Q7 aligned supplier qualification, compliant documentation, and inventory control that supports global regulatory readiness (US FDA / EU GMP / Indian approvals)

Urgent opening for Head QA with rich experience in MHRA site. Job location Chandigarh

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...

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...

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, I...

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 and review Peptide API Drug Master Files (DMFs) for submission to the US FDA and other regulatory agencies. Handle deficiency responses and interact with regulatory authorities for query resolution and clarification. Prepare and manage ANDA Drug Substance Modules and support associated submissions and updates. Compile and submit DMFs, and support any lifecycle management or post-submission queries. Maintain current knowledge of regulatory guidelines and ensure regulatory compliance across all submissions. Participate in internal and external project discussions and contribute to the preparation of regulatory project presentation slides and documentation. Ensure coordination between...

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: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 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 Help clients transform their compliance function from reactive to proactive thr...

The candidate will be responsible for the proper receipt, storage, and GMP-compliant dispensing of raw materials used in pharmaceutical production Perform raw material dispensing activity in designated dispensing booths under controlled conditions.. Required Candidate profile Receive, inspect & label incoming raw materials as per SOP Coordinate with the QA, Production & QC department during material movement Ensure adherence to GMP, GDP & safety guideline during dispensing

Role & responsibilities Manage technology transfer activities from development to commercial manufacturing for OSD tablets. Oversee and execute process scale-up, process optimization, and validation to ensure smooth transition into commercial production. Maintain an in-depth knowledge of USFDA regulations for OSD products and ensure compliance with all regulatory requirements during tech transfer activities. Work closely with R&D, manufacturing, and quality teams to address any technical challenges during tech transfer. Preferred candidate profile Prefered candidates from OSD (manufacture Tablets , capsules,)background . USFDA experince is must Its a plant based role.

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full sala...

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbei...

Role & responsibilities: To enhance the quality system by imparting cGMP knowledge and updating regulatory requirements to the sites. To provide new regulatory guidance and technical documents to the site. To maintain a quality intelligence database and inform the concerned site about current regulatory requirements, updates and changes as and when required. To prepare corporate quality policy, standard practices, and corporate directives for system harmonization across all sites. To evaluate and ensure continual improvement of the quality management system. To verify policy implementation at the site and extend the identified gaps to the site for compliance. To review and evaluate regulator...

Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in ...

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Greetings from Zydus! We have an exciting opportunity for candidates who have experience in Market Complaints. Department: Packing Role: Market Complaint / Investigation Location : Ahmedabad Interested candidates are requested to send their CV on vaibhavi.harish2@zyduslife.com or whatsapp on 6358958368.

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessmen...

As a leader in utility systems management within an API manufacturing facility and drug product filling and packing line equipment, you will be responsible for overseeing the operation and maintenance of various utility systems including Brine chillers, Air compressors, HVAC, N2 plant, Air dryer, and Chilled water chillers. Your primary focus will be to ensure the 24x7 availability of utilities to support uninterrupted manufacturing processes. Your key responsibilities will include planning and implementing preventive and breakdown maintenance schedules, ensuring compliance with cGMP, USFDA, and other regulatory standards, and leading utility qualifications and supporting audits and inspecti...

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...