398 Anda Jobs - Page 10

Regulatory Affairs Associate II Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate II Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate II is responsible for preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work with minimal supervision and pos...

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis 32S/32P Reference Standards 32S/32P Characterization of Impurities 32S/32P Justification of Specification 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report bas...

Regulatory Affairs Associate III, Labeling, Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate III, Labeling, Labeling Who we are The opportunity The RA Associate III is responsible for preparing and/or reviewing high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work independentl...

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Cli...

Develop tablet/capsule formulations for regulated markets (US/EU). Conduct pre-formulation, prototype trials, and scale-up. Execute lab, exhibit, and validation batches. Prepare technical documents for ANDA filings. Support tech transfer and respond to regulatory queries.

Specialized expertise in Inhaler Products including Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI). Method development, validation, and forced degradation studies specific to inhalation dosage forms. Execution and support of technology transfer for analytical methods related to MDI/DPI. Ensure compliance with Quality Assurance systems and applicable regulatory guidelines (ICH, FDA, EMA). Lead analytical activities for ANDA and NDA projects for respiratory products. Coordinate with cross-functional teams for project planning, documentation , and timely regulatory submissions. Review and preparation of analytical method validation protocols, reports, and supporting documentation for...

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical a...

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...

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...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP for Oil & Gas Joint Venture Accounting Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also ...

Reviewing submission related documents including Inactive Ingredient Evaluation, Q1/Q2, Product Development Report, Quality Plan, Product Manual, Trade dress, Specifications, Master Packaging Card and Validation Protocols/Reports etc. DMF Review for ANDA submissions. Outlining requirements for labelling, storage and packaging for FDA submission. Compilation of ANDA sections of US market for sterile dosage form. Review of manufacturing related documents such as BMR, BPR and Stability study Protocols /Reports etc. To draft response and timely submission for regulatory deficiencies. To coordinate with cross-functional teams for regulatory requirements. Keeping up to date with regulatory guideli...

: Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis - 32S/32P Reference Standards - 32S/32P Characterization of Impurities - 32S/32P Justification of Specification - 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification ...

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

•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.

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...

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Prepare DMFs (Dossier Management Facility) for regulatory submissions. Ensure compliance with FDA regulations and guidelines throughout product lifecycle management. Collaborate with cross-functional teams to develop formulations that meet regulatory requirements. Provide expertise on drug regulatory affairs, including labeling, claims, and risk assessment. Desired Candidate Profile M.Pharma degree from a recognized institution. Minimum 15-24 years of experience in Regulatory Affairs - Formulations. Strong understanding of FDA regulations and guidelines. Excellent communication skills for effe...

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...

Role & responsibilities Knowledge about countroller ,servo ,vacuum And Pneumatics System Of equipment Root Cause Analysis and Problem Solving knowledge about cpk And GRR Knowledge About Glue Dispensers Machines Like ANDA Asymtek and Camalot Machines

Job Summary As a Sr. Consultant specializing in Devices you will play a pivotal role in driving innovative solutions and strategies for our clients. With a hybrid work model and day shifts you will collaborate with cross-functional teams to enhance device-related processes and outcomes. Your expertise will contribute to the companys mission of delivering cutting-edge technology solutions that positively impact society. Responsibilities Lead the development and implementation of device strategies to optimize client outcomes and enhance operational efficiency. Oversee the analysis of device-related data to identify trends and opportunities for improvement. Provide expert guidance on device sel...

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...

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate I Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate I, under direct supervision, is responsible for the preparation and revision of high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2, if required, while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of US FDA labeling regulations and guidances to the level of applying them effec...

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Appian Process Automation Good to have skills : NAMinimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications funct...

Alembic Group is looking for Senior Manager - Formulation Development to join our dynamic team and embark on a rewarding career journey Delegating responsibilities and supervising business operations Hiring, training, motivating and coaching employees as they provide attentive, efficient service to customers, assessing employee performance and providing helpful feedback and training opportunities. Resolving conflicts or complaints from customers and employees. Monitoring store activity and ensuring it is properly provisioned and staffed. Analyzing information and processes and developing more effective or efficient processes and strategies. Establishing and achieving business and profit obje...

Alembic Group is looking for Junior Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey They work under the guidance of senior executives and managers to support the organizations goals and objectives Must have excellent written and verbal communication skillsMust be able to analyze complex problems and develop effective solutions Managing internal and external communication, including preparing reports, presentations, and other materials