331 Usfda Jobs - Page 3

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Lead global industry marketing programs Drive and execute sponsorship & participation in industry events Develop marketing artefacts and collateral along with messaging for the website Formulate & work with Inside Sales & external vendors on demand-gen programs Support the analyst relations program & garner mentions by driving participation in relevant studies

To perform preventive maintenance in co-ordination with the plant as per schedule. To maintain records of preventive maintenance (Reactor, Centrifuge, RCVD, ANFD, Vacuum Pump, Centrifugal Pump), break down jobs and instrument calibration. To perform calibration of instruments as per schedule. To monitor safe work environment. To monitor and maintain good housekeeping in respective areas. To perform and achieve department objectives. Awareness and documentation work of IMS, cGMP and USFDA briefly. To take the corrective action against non-conformance arising out of engineering activities for mitigate the Environment impacts and OHSAS impacts. To perform other responsibilities, as assigned by Superiors.

Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.

" 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 manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization ",

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 from FDA Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS) Timely submission of REMS Review of revised artworks

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 and are exporting to over 10 countries from India currently. We have blocked out capacities in over 50 plants in India including US FDA approved facilities. We are 150 people strong and have offices in India, UAE and Indonesia. We are in the process of setting up our office in Delaware for our North America business. Location : Bangalore & Mumbai Responsibilities As we work towards establishing our presence both domestically and globally, we are looking to hire a leader to build and expand the business and team there. Opportunity would entail- Develop and execute strategic export sales plans tailored to different chemical verticals to achieve revenue and growth targets. Identify and penetrate new domestic and international markets, ensuring a diversified client base across regions. Build and nurture long-term relationships with distributors, contractors, and key clients to foster trust and repeat business. Drive revenue through strategic market opportunities, upselling, and effective client management. Ensure all sales operations adhere to international trade and regulatory standards. Stay updated on trends, innovations, and competitors in the chemical sectors to maintain a competitive edge. Qualifications An ideal candidate would have following qualifications- Strong understanding of global market trends, applications, and regulations in relevant chemical industries. Proven track record of achieving sales growth in domestic and international markets. In-depth knowledge of industry-specific applications and market dynamics. Exceptional negotiation and communication skills. A robust network of distributors, contractors, and clients in international markets.plus.

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. Handle expense reports, invoices, and budget tracking as needed. Maintain strict confidentiality and discretion in all interactions. Taking care of all activities related to SVPs office. Visa processing. Maintaining & Updating tracking tracker. Qualifications Bachelors degree preferred; equivalent experience considered. Minimum of 5 years of experience in an executive support role, preferably supporting C-level or SVP executives. Exceptional organizational, time management, and multitasking abilities. Strong verbal and written communication skills. Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with collaboration tools like Teams and Concur is a plus.

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 manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

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 eligibility for Intra-Company Transfers (ICT) and other work permits in Canada. Providing initial consultations to clients regarding their options for bringing employees to Canada through ICT and other programs. Intra-Company Transfers (ICT): Managing the process of transferring employees from a foreign office to a Canadian office of the same company. Advising employees on the requirements and documentation needed for ICT applications. Assisting with the preparation and submission of ICT applications to Immigration, Refugees and Citizenship Canada (IRCC). Labour Market Impact Assessments (LMIA): Assisting in obtaining LMIA approval to hire foreign workers for positions where there are no qualified Canadian workers available. Advising on the LMIA application process, including advertising requirements and application submission. Assisting with the preparation and submission of LMIA applications to Employment and Social Development Canada (ESDC). Work Permits: Assisting clients in obtaining work permits for foreign workers in Canada, including open work permits and employer-specific ICT work permit. Advising clients on the eligibility criteria, documentation requirements, and application process for various types of work permits. Document Preparation and Review: Assisting employees in preparing and reviewing required immigration documents, including work permit applications, LMIA applications, and supporting documentation. Ensuring that all required documents are accurately completed and submitted in a timely manner. Case Management: Managing multiple immigration cases simultaneously, particularly those related to ICT, LMIA, and work permits. Keeping stakeholders informed about the progress of their applications and any changes in immigration laws or policies that may affect their case. Legal Research: Staying up-to-date with changes in Canadian immigration laws, policies, and procedures related to ICT, LMIA, and work permits. Conducting legal research to support immigration cases in these specific areas. Compliance: Ensuring that all immigration activities comply with Canadian immigration laws and regulations, particularly those related to ICT, LMIA, and work permits. Maintaining confidentiality and privacy of client information. Administrative Tasks: Maintaining accurate records of client interactions and case details, particularly those related to ICT, LMIA, and work permits. Handling administrative tasks related to client files, such as organizing documents and correspondence.

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 medical specialists, such as neurologists, audiologist, and speech therapists, to provide comprehensive patient care.Maintaining accurate and complete patient records, including medical history, exam results, diagnostic images, and treatment plans.Participating in continuing education programs and conferences to maintain and improve surgical skills and knowledge.Ensuring that all medical equipment is properly maintained and in compliance with safety regulations.

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 regulatory teams to ensure consistent strategies and compliance. Requirement: Master s degree in Pharmacy or a related field 5 8 years of hands-on experience in regulatory affairs for medical devices and experience with Class C & D devices preferred Strong knowledge of CDSCO regulations and submission pathways Excellent communication and project management skills Familiarity with ISO 13485, EU MDR, and US FDA regulations is a plus

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 blinded sample size re-estimation and interim analysis Review and provide inputs to statistical analysis plan and CRF Review tables, listings, figures and clinical study reports Collaborate with internal and external stakeholders (CROs) to resolve issues around statistics Respond to agency queries on issues related to biostatistics Qualification : MSc., PhD in Biostatistics Experience : 10-15 years' experience in a Pharma / CRO

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-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

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 procedure. 3. Manage master and obsolete copies of SOPs, specifications, ATRs, worksheets, stability protocols, BMRs, BFRs, BPRs, etc. 4. Track SOPs, procedures, specifications, etc., for revision according to their validity period. 5. Responsible for archival management, including archival and retrieval of documents as required. 6. Perform login and review of quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 7. Track all quality management system documents till closure, including change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 8. Generate monthly tracking reports for quality management systems as per defined procedures. 9. Handle product quality complaints (Adverse Events) and medical inquiry reconciliation tracker for the Digwal site, coordinating with Pharmacovigilance team for adverse events as applicable. 10. Review and approve investigation reports, risk assessment reports, and ensure the implementation and effectiveness assessment of CAPAs. 11. Review quality system documents such as protocols, reports, procedures, APOR, trend analysis reports, continual process verification reports, etc., as required. 12. Share documents with the Regulatory Affairs department for filing updates based on change control implementation. 13. Prepare and review customer and external audit compliance reports. 14. Review and approve analytical reports such as batch analysis, standards, stability studies, etc. 15. Perform GMP verification and compliance review. 16. Ensure compliance with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, including the usage of Personal Protective Equipment (PPE) where applicable. Qualifications: Bachelors degree in pharmacy, Chemistry, or related field. Master's degree preferred. 8-12 years of relevant experience in pharmaceutical Quality Assurance/QMS roles( API / API & Formulations ) Strong understanding of regulatory requirements and quality standards in the pharmaceutical industry. Excellent organizational, communication, and problem-solving skills. Ability to work effectively in a team and independently, with attention to detail and accuracy Skills: Proficiency in handling documentation and data management systems, particularly Harmony. Strong organizational skills with attention to detail and the ability to manage multiple priorities.

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 guidelines, RMG (Revised Manufacturing Guidelines). Proficiency in operating various types of granulation equipment.

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 / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations / Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing operations / QMS activities Time and Venue : 20th July 2025 09:30 Hrs to 18:00 Hrs ______________________________________________________ PAPAYA TREE Group of Hotels - Indore, Address: AB Road , Near Dr. Hardia Eye Clinic, Rau, Indore, MP ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Note: Having relevant qualification only can attend the scheduled walk-in.

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/She shall be responsible for the smooth operations of the equipments/Instruments. He/ She shall be responsible for signing the test certificate / test reports. He/ She shall be responsible for verifying the outside calibration certificates. He/She shall be responsible for the supervision of technical staff working under him/ her. He/She shall be responsible for filling the change control, deviation control, OOS, CAPA raised by technical department. He/She shall be responsible for the preparing / reviewing the scope as per requirements. He/She shall ensure that the glassware used in his / her section should be duly calibrated or verified as required. He/She shall be responsible for the qualification and calibration of new instruments/ equipment. He/She shall be responsible for the maintaining overall quality as per ISO/IEC 17025. He/She shall be responsible for all the relevant works of VP- Technical/GM Operation in his absence.