354 Dmf Jobs - Page 9

Roles and Responsibilities Review documents from various departments to compile regulatory submission. Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMF s to ensure regulatory complience. Coordinate with CFT to address deficiency and feedback from RA and customers. Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires. Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance. Respond promptly to technical queries from regulatory bodies and customers.

Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COA s and other regulatory documents as per the needed) to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders: NTO, Reg CMC, Global labelling & RA Ops for renewals SCM, Tech Ops for Regulatory samples, HA such as USFDA, Swiss medic/EMA & Consular Services for certificates etc, External Service providers Support for planning and management of timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufact...

B.Pharm / M.Pharm with 2 to 6 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

JD To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats / and country specific format, DMF verification, technical data verification for all CIS Countries and other country as per company requirements. Responsible for final review of dossier before submission To coordinate with technical team for documents required for dossier. Reviewing artwork for products as per relevant regulatory authority requirements. To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the regulatory and code of conduct requirements; Provide responses to regulatory agencies regarding product information or issues. Impl...

Heres how youll contribute: Writing skills, specifically around describing a scene and driving logic Fluent in English language, familiarity with road signs in the US (Other regions including EU is a bonus) AV labeling experience (bounding boxes, etc) College Educated

Support group reporting team in loading data onto HFM from onestream. Clearing validations at HFM / OS Preparation of control sheet OS to HFM walk on monthly basis Assistance during H1 / Annual group audit / FC1 and budget submission Migration of onestream to SAP etc. Requirements: Candidate must be pursuing CA course and eligible for industrial training as per ICAI internship guidelines Good exposure in accounting, taxation, financial analysis, and statutory audits during articleship period Strong understanding of IND-AS, Companies Act, and other relevant accounting standards Advanced proficiency in MS Excel (including financial modeling, pivot tables, VLOOKUP)

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...

Role Description The Staff Accountant will be responsible for processing bank receipts and payments, and performing bank reconciliations. The role requires working effectively under tight deadlines, attention to detail, and high-quality analyses. The position reports to the Senior Accountant. Role and responsibilities Bank accounting receipts and payments (US/EMEA/APAC) Managing and creating bank payment runs Performing daily bank reconciliations Keeping track of all bank charges and interest cost Managing Month End Close for treasuring and banking, and related tasks like Bank module close, bank reconciliation, interest cost accruals, forex revaluation, etc. Formulate Standard Operating Proc...

Responsibilities: * Lead regulatory strategy development & implementation * Manage dossier preparation, compilation & submissions * Oversee drug regulatory affairs in Row & Emerging markets

You will be working as a Dynamics F&O Technical Resource, focusing on customizations, validations, and verifications. Your role may also involve assisting with configurations, requirements gathering, client communications, documentation, maintenance, and support for projects. Key Responsibilities: - Performing customizations through coding and debugging - Assisting in configurations - Engaging in client communications - Managing data migration and integrations - Conducting training sessions - Supporting and maintaining activities - Documenting processes - Testing and debugging - Ability to work on previous versions (AX 2009, 2012, 2012 R2/R3) - Handling other relevant activities/tasks as req...

Aerospace Engineering: Operator/ Setter/HMC/VMC/VTL/Fanuc - with Free Food and Accommodation. Role & responsibilities Ability to read and understand Customer drawings & its constituents, Standard Notes, and Standard Operating Procedures Carry out production, inspection, packaging and machine operation duties Set up machinery and ensure all materials are readily available Ability to create and run program to support in the part prove out Ability to maintain and follow all the documents, created to flow the production with no interrupts Capable to work individually at machinery Effectively monitor production equipment Assist the shop technicians and materials clerk as necessary Perform appropr...

Role & responsibilities • Process development and optimization before scale-up activities, Lab demonstration & scale up of optimized process. Process development report, Investigation report, TT report, solvent recovery report preparation. Impurity characterization by using spectroscopic technique like NMR, IR, UV, Mass. Working towards cost reduction and time cycle reduction by debottlenecking of process. Utility performance monitoring, working towards the efficiency improvements. To find out the root cause of the OOS in plant and provide the CAPA with justification. Tech transfer of new molecules for DMF and NDMF with desired yield, Quality, Safety (Zero Accident) as planned by R&D. Partic...

Recorders and Medicare Systems Pvt Ltd is looking for RA Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available ...

Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and othe...

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...

Number of requirements 1 / Level 3 rd Experience: 6 to 7 Years Job Overview: As a SAP CRM Consultant specializing in Application Support Management, the primary responsibility will be to provide ongoing application support, maintenance, and request fulfillment enhancements for SAP CRM systems. The consultant would have to work closely with business users to understand their needs and ensure that the CRM application remains reliable, secure, and aligned with GB ( Business Unit) goals. Qualifications: Bachelor's degree in a relevant field, such as Computer Science, Information Technology, or Business. Proven experience in SAP CRM On Premise application support and management. ( 6-7 years) Stro...

Note to Hiring Manager: In support of BNP Paribas APAC's Diversity Commitment, Hiring Managers are to consider at least 1 Asia Pacific national, 1 male and 1 female candidate for the position to be filled. Position Purpose Facilitating transaction processing of instructions received from Client to ensure all settlement of trades in Global markets. Providing round the clock service to cover client queries across ASIA, EMEA and US regions. Reconciling client positions to match with the market positions. Being a team player and a manager to achieve team co-ordination, adhere to BNP policies and follow the agreed timelines to avoid any breach in SLA. Responsibilities Job summary Roles & Responsi...

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.

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.

Role Overview: As an experienced analytical development scientist at Dr. Reddys Laboratories Ltd., your main responsibility will be to execute analytical activities based on priorities and established timelines. You will be required to provide timely analytical delivery for stability testing, test method development/validation, method transfers, and other related requests from Research & Development (R&D) or formulation development. Key Responsibilities: - Conduct Literature survey and prepare analytical strategy for assigned projects. Should have a minimum understanding of DMF and test methods of drug substance, etc. - Perform analytical method development of Viscosity, PSD, GSD, Assay, RS,...

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Defi...

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Area Of Responsibility - To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements. - To review outsourced intermediates and APIs for regulatory adequacy to support Procurement Team in vendor selection and DF-Regulatory for ANDA/MA submission. - To coordinate & support Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies for regulatory submission...