933 Usfda Jobs - Page 25

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sitedat Roorkee, Uttarakhand and Salisbury, Maryland, USAengaged in manufacturing of Tablets and Capsules. The man...

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification fr...

About Us We are a specialty chemicals manufacturing company with a full stack solution from R&D to manufacturing and doorstep delivery of innovative chemicals. Headquartered in Bengaluru, India we cater to pharmaceutical, agrochemical, industrial chemicals, personal care, and home care industries. Our B2B fulfillment platform supports businesses globally in developing and manufacturing chemicals from lab to commercial scale. With a team of in-house R&D experts and scientists, we offer custom synthesis and route scouting services to support manufacturers in product development. We are VC backed and have raised $40MM. We have scaled our business to $35MM in annualized revenue in the last year ...

Overview We are seeking a highly organized, proactive, and detail-oriented Executive Assistant to support our Senior Vice President (SVP). This role requires a high level of professionalism, discretion, and the ability to anticipate needs while managing a wide range of administrative and executive support tasks in a fast-paced environment. Responsibilities Manage and optimize the SVPs calendar, scheduling meetings, appointments, and travel arrangements. Prepare, review, and organize correspondence and other confidential documents. Coordinate internal and external meetings, including logistics, agendas, and follow-ups. Serve as a liaison between the SVP and internal/external stakeholders. Han...

Technical Skill : Routine Operation & Analysis API Products HPLC, WET Lab Analysis

1.Routine Operation & Analysis API Products 2.HPLC, WET Lab Analysis

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The m...

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 ...

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other...

Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO. Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments). Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants. Support Quality Assurance in audits, product recalls, and field safety corrective actions. Ensure compliance with India-specific labeling, documentation, and advertising regulations. Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams. Maintain regulatory files and tracking systems for timely renewals and updates. Collaborate with global...

Desired Experience Experience of biostatistics in regulated markets Interacted with regulatory agencies (FDA/EMA/PMDA) Experience of biosimilar product development Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis Knowledge of using relevant software including PASS, SAS, SPSS, R Job Description Prepare scientifically sound statistical design for clinical trials Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA) Perform meta-analysis and calculate sample size Prepare statistical justifications for agency interactions (FDA/EMA/PMDA) Review and provide inputs to statistical sections of clinical trial protocol Plan and perform blind...

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top...

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing. Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR). Conduct in-process checks and ensure batch release activities. Required Candidate profile Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.). Review of analytical documents, stability protocols, validation protocols & reports. Immediate to 30 days preferred

Roles and Responsibilities Ensure compliance with USFDA, MHRA, and other global regulations through quality control management. Conduct regular audits to identify areas of improvement in production processes. Collaborate with cross-functional teams to resolve quality issues and improve overall product quality. Develop and implement corrective actions plans to address non-conformities found during audits. Desired Candidate Profile 10-15 years of experience in pharmaceutical industry with expertise in HPLC analysis. B.Tech/B.E. degree in Chemical Engineering or related field;. Strong understanding of GMP guidelines, ISO standards, and regulatory requirements such as USFDA & MHRA.

The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes. Key Responsibilities: Key Responsibilities: 1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements. 2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the ...

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports.

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR).

Roles and Responsibilities Operate granulation equipment such as roller compactor, fluid bed dryer, etc. to produce high-quality granules. Monitor and control process parameters to ensure product quality and consistency. Perform routine maintenance tasks on equipment to prevent breakdowns and optimize performance. Collaborate with other departments (e.g., formulation, packaging) to ensure smooth production operations. Ensure compliance with cGMP regulations and company policies. Desired Candidate Profile 2-7 years of experience in OSD (Oral Solid Dose) manufacturing or related field. B.Pharma degree from a recognized institution. Strong understanding of FBD (Formulation & Bulk Drugs), USFDA ...

Walk-in @ Indore We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned, If any of the requirement is matching your current job profile, kindly walk-in with your latest resume. *Job Location: Matoda, Ahmedabad, Gujarat. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / IPQA (OSD) (Officer / Senior Officer / Execut...

Chemical and Instrumental analysis and review of in process/ intermediate/finished API sample as per the specification and STP. Quality Control, Quality compliance, method Validation, Analytical Technology Transfer, Vendor Analytical method verification/ validation, Faced internal audits and regulatory audit (USFDA, EUGMP, ROW MARKET, WHO-Geneva). HPLC, GC, Optimization of analytical methods for qualification and release testing of raw materials, In-process materials, Intermediates, Finished products, etc.

Role & responsibilities Manager technical is the In-charge of Analytical Division. He/She shall report to the SBU-head about all the activities in the Analytical Division. He/She shall look after all the operations of the Division under the guidance/ supervision of SBU-Head. He/She shall be responsible for the standardization and validation of the test methods. He/She shall be responsible for ensuring the availability of the reference material / working reference standard. He/She shall be responsible for assigning the jobs to the analyst as per their calibre. He/She shall be responsible for checking the calculation part and reporting of the results before sending for authorized signatory. He...

Job Title: Manager / Sr. Manager Engineering (Projects) Location : Central India (Greenfield Project) Responsibilities- Overall experience in USFDA Injectable Plants, handling Qualification of HVAC, Designing, Installation, Commissioning Clean Utilities Black Utilities Overall, In charge of Piping, Utilities & HVAC Systems for installations at Site. Based on the received drawings & documents, assign work and timelines and ensures the implementation of the same. Ensure collection of data; do analysis to achieve relevant construction quality and safety. Help overcome constraints, work out alternatives to the design in case of difficulties Retention of records in respective area. Preparation & ...

WALKIN DRIVE - REGULATORY AFFAIRS @ BARODA (FORMULATIONS) DATE : SUNDAY, 13TH JULY 2025 || TIME : 9.30 AM VENUE : SUN PHARMACEUTICAL INDUSTRIES LIMITED, NEAR AKSHAR CHOWK, SUN PHARMA ROAD, TANDALJA, VADODARA - 390012| DEPARTMENT : REGULATORY AFFAIRS - US MARKET | LABELLING | PLANT RA EXPERIENCE RANGE : 2-8 YEARS GRADE ; EXECUTIVE / SR EXECUTIVE JD: FOR US MARKET ; 1) Compilation , review of dossier for US , EU , AU, Canada & IL market (ORALS/NON ORALS) 2) Review of query response prepared and compiled by regulatory associates 3) Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management FOR LABELING: 1) Preparation and reviewing ...

Long Description Annual maintenance contract preparation and preventive maintenance of QC instrument as per approved procedure. Breakdown handling of QC instrument as per approved procedure. Upkeep the records for preventive maintenance and breakdown in SAP. Qualification of New instruments with complete documentation. To participate in failure investigations related to instrument malfunctions. To impart training to the analysts for instrument maintenance and troubleshooting. Co-ordination with service engineer for service/ breakdown related activities To maintain good laboratory practices and discipline in respective work area. Actively taking part in cGMP, training and SOP training as and ...

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a to Submissions Senior Publisher to join our A-team (hybrid). The Submissions Senior Publishe are responsible for preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regula...