933 Usfda Jobs - Page 15

Role Overview: You should possess a Bachelor's or Master's degree in Pharmacy or Science with 3-8 years of relevant experience. Immediate joiners are preferred for this position. As a member of the team, your responsibilities will include conducting HPLC analysis of Solid Orals and Nasal products, hands-on experience in Quality Control activities related to Raw Materials, Packing, In Process, and Finished Products, as well as ensuring compliance with GMP/GLP practices. The preferred candidate will have 2-8 years of experience and prior exposure to working in regulated plants, specifically those approved by USFDA/MHRA. Key Responsibilities: - Conduct HPLC analysis of Solid Orals and Nasal pro...

Job Title:- Assistant / Deputy Manager – Regulatory Affairs (US Market) We are hiring Regulatory Affairs professional for the US Market. The candidate will be responsible for preparing, reviewing, and submitting ANDA

Manufacturing Systems & Compliance Support manufacturing and laboratory systems (e.g., LIMS, MES, SCADA, PLCs, BAS, and ERP). Ensure IT systems comply with GxP regulations and 21 CFR Part 11. Support and maintain including documentation as per SOPs Required Candidate profile IT experience in a manufacturing environment (pharma preferred). Familiarity with GMP, GAMP5, and regulatory units (FDA, EMA). Supporting validated systems and documentation for audits/inspections. Perks and benefits Accommodation & Transportation

The role involves preparing and reviewing regulatory documents, ensuring compliance with national and international guidelines, and supporting product registration processes. Required Candidate profile Looking for a Regulatory Affairs Officer with 2-3 years of experience in the Pharma/API sector. Candidates should have strong MS Office skills and good communication abilities.

Developing a deep expertise and understanding of Adobes Enterprise Term agreements (Digital Media Products) Conditions of Service & Commercial Terms. Researching customer contracts and purchasing history in Adobes various CRM systems in order to build timely and accurate quotations for Anniversary Payment within the portfolio Engaging with Adobe end users, distributors and resellers, secure Anniversary Purchase orders on time and support revenue growth through True-Up motion. Engaging with business partners in sales, finance, etc. to resolve issues raised by Customers or partners related to anniversary & True-Up payments Securing and validating Purchase orders on time, driving maximum recurr...

As a Consultant, you will be a key resource on client engagement. Be up to date with key technical and functional skills, and industry trends Skills and attributes for success Experience in Transfer Pricing and/or direct tax domain Skills and attributes To qualify for the role you must have Qualification Chartetred Accountant/ Postgraduate in Economics / MBA Finance Experience Prior experience/insight into Transfer Pricing Regulations (India and OECD) and/or India Income Tax provisions are desirable.

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Pr...

About The Role : Job Title Bond Analytics Analyst LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader incash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments ofcorporate and commercial clients and financial institutionsacross the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Securities Service (TSS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Securities Services team at D...

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals...

EXPRIENCE: 14 - 20 Years EDUCATIONS: M.SC/B.SC/B.PHARMA DESIGNATIONS: DGM-QC PREFRIED PROFILES: Having a minimum of 5 years experience in a USFDA-approved plant as a QC Team Lead." JOB RESPONSIBILITIES: 1. OVERALL TO PLAN & CONTROL QC AND QC MICRO SHOP FLOOR OPERATION ACTIVITIES IN SYSTEMATIC WAYS & IN TIMELY MANNER TO ASCERTAIN AND ALIGN PRODUCTION SAMPLES GET ANALYSED TO SUBMIT REPORTS. 2. TO WORK COHESIVELY WITH CROSS FUNCTION TEAM TO ACHIEVE COMMON GOAL OF ORGANIZATION. 3. ALL TIME READINESS IN COMPLAINT MODE FOR AUDIT ACROSS QC AREAS. 4. TO ATTEND MANAGEMENT REVIEW MEETINGS WITH COMPLETE PROGRESS OF QC STATUS. 5. TO MAINTAIN DATA INTEGRITY IN THE LAB. 6. TO PROVIDE SAFE WORK ENVIRONMENT...

Channel Sales Operations Associate will be responsible for providing remote sales operations support forthe BMC Sales Ecosystem across all regions around the globe. Supporting a variety of channel partner types including distributors, value-added resellers, Marketzone and GOSI partners. Main responsibilities will include managing to close all Partner agreement requests, updating SFDC and back-office systems to ensure BMC Partners can transact successfully with BMC and engage with the BMC partner program benefits. The objectives for this role will be to ensure high quality service delivery, improve transaction velocity, and drive automation and optimization in day-to-day work. Here is how, th...

Oversee complete Production & Manufacturing operations at the Pharmaceutical Formulation Unit Ensure smooth execution of batch manufacturing for OSD (Tablets, Capsules, Dry Syrups) Ensure compliance with FDA regulations and GMP guidelines Monitor production efficiency, process optimization & manpower management Coordinate with QA, QC, and Regulatory teams for smooth operations Handle regulatory audits, validation, and documentation processes OSD Manufacturing Tablets, Capsules, Dry Syrups FDA Approval & Regulatory Compliance (WHO-GMP, Schedule M preferred) Production Planning & Process Optimization Team Leadership & Manpower Management

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time subm...

Job Title: Corporate Quality Assurance Head Location: Vadodara Position Level: GM / Sr GM / Vice President (VP) Job Description: Responsibilities: Quality Management System Leadership: Develop, implement, and oversee the Corporate Quality Management System for injectables, oral solid dosage formulations, and active pharmaceutical ingredients (APIs). Ensure compliance with global regulatory standards and industry best practices. Regulatory Compliance: Stay abreast of global regulatory requirements for pharmaceutical manufacturing, ensuring the company's adherence to guidelines for injectables, oral solid dosage formulations, and APIs. Represent the company during regulatory inspections and au...

Role Overview: 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. Your primary focus will be to ensure the 24x7 availability of utilities to support uninterrupted manufacturing processes. Key Responsibilities: - Plan and implement preventive and breakdown maintenance schedules for utility systems including Brine chillers, Air compressors, HVAC, N2 plant, Air dryer, and Chilled water chillers. - Ensure compliance with cGMP, USFDA, and other regulatory standards. - Lead utility qualifications and support audits and ins...

Executive Regulatory Affairs (Europe Market) – Ahmedabad | M.Sc./B.Tech | 3–5 yrs exp. | Prepare & review eCTD dossiers, manage DMFs, submissions, change controls, ensure EMA/USFDA/ICH compliance, coordinate cross-teams, expertise in eCTD software.

Position : 2 Position Education: Be- Mechanical Preferred candidate profile Plant Maintenance Process Equipment - Injectable Process Equipment - OSD

Maintain H1B petitions including annual H-1B CAP, extensions of current visas and transfer petitions for new employees. Prepare in-house documents and petitions for other visas including but not limited to F-1, L1, and dependent visas (H4, L2 etc). Have ability to lead immigration process from start to finish, working with non-immigrant & immigrant Visa applications and processes (H1-B, H-4, L-1, TN, and EB non-immigrant petitions, RFE, etc.), EAD renewals of employees and dependents. Maintain Public Access Files ensuring compliance, documentation and execution of immigration policies and procedures. Experience of handling FDNS site visits, PAF, DOL audits. Consultation: Assessing employees ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 You will be aligned ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy 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 aligne...

Company: Strides Pharma Science Ltd Department: Quality Control (QC) Position: Senior Executive Job Location: Alathur, Chennai Qualification: M.Sc. (Chemistry), B-Pharm, M-Pharm Experience: 4.5 to 8 Years Skills required: Experience on Raw material, In-process, Finished product, Stability and Microbiological testing. Work experience on FDA regulatory plants Flexible to work in shifts Job responsibility: Handling of Sophisticated instruments such as HPLC, GC, UPLC, UV, AAS & Dissolution Tester Analysis in LIMS e-RDS Experience on Microbiological testing Instrument Qualification knowledge on IQ, OQ, PQ. Regards, Srinidhi S HR Talent Acquisition

Roles and Responsibilities : Maintain client relations to build excellent reputation for service and produce repeat business. Interact regularly with top ten accounts related to weekly selling, deliveries and stock availability. Maintaining contact with existing clients to ensure that they are satisfied with their services Building relationships with existing clients to ensure repeat business and new business opportunities Managing existing customer accounts by ensuring that existing customers remain satisfied with company products and services. Developing and implementing effective account plans to retain existing customers. Identifying customer needs and communicating how company products ...

Responsible for supplier audit planning, scheduling, and conduct supplier audits. Responsible for vendor/ supplier quality and management issues. Responsible for implementation of ISO 13485 requirements Responsible for formulating, document, and maintain quality standards and ongoing quality objectives. -Analysis of raw material, In-process samples, and finished product. -Auditing OEM and verify the process control and quality, suggest changes if required to improve quality. -Responsible to escalate technical issues to the design team and Providing product feedback and customer suggestions to the R&D and Product Management team, also tracking the continuous improvement of the products. -Resp...

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes b...

Exciting Career Opportunities at Natco Pharma Limited for the following requirements Work Location: Kothur (Formulation Division) Interview Date: Saturday, 20th September 2025 Time: 9:00 AM to 2:00 PM Venue: Natco House, Road No.-2, Banjara Hills, Hyderabad 500034 (Opp. A.P. Productivity Council) Open Positions: Analyst - Quality Control (OSD & Sterile) Experience: 3 to 5 Years Qualification: B. Pharmacy / M. Pharmacy / M.Sc (Organic/Analytical/General) Chemistry Key Responsibilities: Adherence to GLP, GDP, cGMP, and ALCOA+ standards. Analysis of RM / IP / FP samples, Operation and troubleshooting of instruments such as HPLC, UV, KF, IR, and Dissolution Apparatus. Demonstration of QC testing...