354 Dmf Jobs - Page 10

As a Jr. Officer to Sr. Officer at our company, you will be responsible for the following: - Preparation of dossiers and documents in compliance with CTD, ACTD, and country-specific guidelines. - Reviewing dossiers, DMF, and technical documents. - Addressing queries raised by regulatory authorities. Qualification Required: - Must have an M.Pharm degree. The work location for this position is in Jarod, Vadodara, Gujarat. Additionally, we offer benefits such as health insurance, leave encashment, life insurance, paid sick time, and provident fund. Please note that this position requires a long-term association agreement with an incentive scheme for 2-3 years.,

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficienc...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

Job Responsibilities- Assisting in developing audit planning documentation addressing scope,auditobjective, budgeted hours, resource plan,and reporting date Complete assignedaudits, addressing allauditobjectives, conducting clientandstatus meetings as required, controlling, monitoring,and reporting onauditprogress, reviewing work papers,and ensuring work papers provide adequate support of conclusions while complying with internal standards for documentation. To monitor the assignment for improving the efficiency of the assignment, manageauditin relation to time and resource budget Will actively check that all findingsandissues are documentedandperform closedown procedures Gatheringandcompili...

Position: AGM Quality Location: Hyderabad Key Responsibilities Lead quality initiatives across plastics processing and molding operations Manage pharma packaging quality and ensure regulatory compliance (DMF filing, ISO, GMP, 15378, etc.) Must Drive process improvements, audits, and risk assessments across multiple units Handle customer and agency audits (USFDA, Health Canada, China DMF, ISO certifications) Implement problem-solving methodologies (Six Sigma, FMEA, RCA, CAPA, SPC, QC tools) Reduce customer complaints, internal rejections, and standardize best practices across sites Partner with plant leadership to execute technical improvement plans, automation, and quality infra upgrades Sup...

review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA Review of DMF; Manages USFDA registration Provides technical review of data and reports to be incorporated into regulatory submissions;

You are invited to join Global Calcium Pvt. Ltd., a prominent API manufacturing company located in Bangalore, India, specializing in speciality API's, benzodiazepines, ophthalmics, oncology, chelated minerals, and organic mineral salts. We are currently seeking talented individuals to fill various roles in the QC Department. Open Positions: - QC ICP-MS Analyst (2 openings) - QC DMF Support (2 openings) - QC Analytical Validation Support (2 openings) - QC Wet Analysis (2 openings) Qualifications: - B.Sc./M.Sc. in Chemistry or related fields - 1 to 4 years of relevant pharmaceutical QC experience - Familiarity with cGMP practices and regulatory compliance Responsibilities: - Perform routine an...

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/pa...

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

WTP OPERATORFollow daily shift activates without deviations. Follow daily operations and logbooks updation as per SOP. Please coordinate with MAC and calibration activity with internal team. WTP snatization activates as per schedule'

The Impact You'll Make As a financial controller within our dynamic finance organisation, you'll play a pivotal role in driving the financial strategy for a substantial ?1 3 billion division Your contribution will not only enhance our financial planning and forecasting capabilities but also significantly bolster our risk management efforts By collaborating closely with product line leaders, you will be instrumental in delivering actionable insights that can transform data into strategic opportunities You will be at the forefront of identifying and modelling financial risks, thus helping to steer performance targets towards successful outcomes Your expertise will aid in shaping decisions that...

Experience of DMF & Regulatory Documentation of Export Market.

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 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 - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, co...

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensu...

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software...

Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures. Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc. Filing amendments, updates with relevant health agencies Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software Preparation of response to queries received from health authorities and customers Evaluation of regulatory impact and review of QMS documentation Coordination with various stake holders at site for documentation Participation in project review meeting regarding new products and providing regulatory feedback Licen...

Role / Nature of Job : Assembly / Machine Operator Follow and support Safety and Environmental practices on the shop floor, including hazard identification and safe working methods, in line with ISO45001 & ISO14001 standards. Operate machines and follow established processes after required training, ensuring adherence to ISO9001:2015 standards. Support shift production targets by executing assigned operations and coordinating with relevant support teams. Maintain discipline in resource usage to support cell-level productivity and cost control (Volume-adjusted VOH). Carry out production activities as per the shift plan to meet internal customer requirements. Build skills through On-the-Job Tr...

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization an...

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

Position: Dynamics 365 F&O Technical Developer Location: Remote Employment Type: Full-Time Experience: 3+ Years About the Role: We are seeking a skilled and experienced Dynamics 365 Finance & Operations (F&O) Technical Developer to join our team. The ideal candidate will have strong expertise in X++ development , extensions , customizations , integrations , and data migrations within the Dynamics 365 F&O ecosystem. This role requires close collaboration with functional consultants, business stakeholders, and cross-functional teams to deliver scalable, high-quality solutions aligned with business requirements. Key Responsibilities Design, develop, and maintain customizations and extensions wi...

You demonstrate strong coding skills using Dynamics AX X++ and related technologies/tools such as DMF, SSRS, SSAS, Workflow, Batch framework, Security framework. You have experience in AX2012/D365FO and its latest releases. You review and understand the functional design of given business requirements for technical solutions and prepare detailed technical design (TDD). You ensure to produce high-quality TDD documents following set standards and templates. You drive/assist technical design on the GAP requirements with other technical teams to maintain consistent technical quality. Engaging in discussions with functional consultants for design clarifications is part of your responsibilities. Y...

Job Purpose Job Purpose Description Key Result Areas/Accountabilities Supporting Actions Accounts Payable & Vendor Compliance Ensure 100% timely processing of AP vouchers and vendor payments, including MSME vendors, by adhering strictly to PO terms, Delegation of Authority (DOA), and retention/LD clause validation. Statutory Compliance & Taxation (GST, TDS, Royalty, etc.) Maintain 100% compliance in GST filings (GSTR-1, GSTR-3B, RCM), Royalty/DMF/NMET payments, and TDS/TCS remittances by adhering to statutory deadlines Audit Readiness & Documentation Ensure timely submission of accurate reports, ledgers, and reconciliations required by internal/external auditors. Fixed Assets & Project Accou...

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia,...

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 ...