354 Dmf Jobs - Page 11

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions...

As a Technical Consultant at EY, you will have the opportunity to work with Microsoft Application Technologies (D365 F&O and AX2012) as part of a globally connected powerhouse of diverse teams. Your main responsibilities will include participating in requirements analysis, collaborating with internal teams for software design and architecture, writing clean and scalable code using MS programming languages, testing and deploying applications and systems, as well as revising, updating, refactoring, and debugging code. You will also be expected to improve existing software, develop documentation throughout the software development life cycle (SDLC), and demonstrate excellent troubleshooting and...

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

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines receive...

Requirement Experience in API Regulatory Affairs Routine job skill: Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile and have ability to work in highly matrixed environment. Attention to detail and accuracy required. Must be able to prioritize with independently/minimal guidance. Ability to handle multiple projects with good prioritization skills. Willingness to complete the work as per the committed timeline. Technical Skills: Sound understanding of drug development regulatory processes and requirements for defined market(s) and able to interpret and apply to projects. Ability to identify inconsistencies and deficiencies in technical ...

JD For D365 F&O Sr. Retail Technical Consultant Job Overview: As a Senior Retail Technical Consultant, you will be responsible for architecting, developing, and supporting complex retail solutions within the Microsoft Dynamics 365 Finance & Operations (F&O) platform. You will play a key technical role in D365 Retail implementations, focusing on POS, Retail HQ, e-commerce integrations, and backend Retail business processes. This role demands deep technical expertise in D365 F&O Retail modules, including development using Retail SDK/Commerce SDK. Key Responsibilities Design and implement end-to-end technical solutions in D365 F&O Retail, including POS (MPOS/CPOS), Retail HQ, Retail Server, and...

Role & responsibilities 1.Ensure proper documentation and fulfillment of statutory requirements with regards to various FDA authorities. 2. Collect information from various departments and prepare DMFs, Dossiers, amendments and supplements etc 3. Submit them to the pertinent regulatory authorities within a specified time frame to get approval. 4. Respond to queries as they arise and ensue that regishation/approvals are $anted without delay. 5. Coordinate customer and reeulatorv audits. 6. Provide compliance to customer complaints by coordination with marketing department. 7. Keep up to date of national and intemational legislations, guidelines (available on websites) and customer practices a...

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...

•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.

To help in coordination of spcification committee meetings. To prepare and review GTPs, Specification and STPs of API / FG for New products. To prepare and review spcifications / STPs / GTPs of the RM/excipients/API/FG for Commercial and CML Products. To coordinate with all concerned departments at R&D and Plant for timely approvals of documents. To review vendors COAs for RM/excipients/API. To Respond the regulatory queries related to analytical documents. To archive the backup raw data respective to the documents prepared. To review NDs and ensure there compliance where required. To review the latest Pharmacopeias and their implementation in existing documents preferably API, excipients an...

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...

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

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

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...

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

Review, compile and Preparation of original drug master file (DMF)/ ASMF as per GUDFA guidance/EMA guidance in eCTD format for various agencies. Review, compile and Preparation of Response to Deficiency as received from Agency. Working on Life Cycle management of DMF including amendment, biannual update, Annual Reports etc. for various markets. Preparation of Applicants Part and sharing with Customers and resolving customers query. Sound knowledge about ICH guidelines GDUFA and EMA guidelines

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

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

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...

Role & responsibilities Prepare CTD dossiers for regulated markets and other markets as per country specific guidelines. Attend to various queries raised by the importing countries wrt to Co.products & dossiers. Coordinate with factory. Preferred candidate profile 1-3 Years Experience In Regulatory Affairs for formulations. Excellent communication skills both written and verbal.

Design in Clutches & DMF Design & Verification in Pass. car & Commercial vehicle segments Working in design activities of Clutch & DMF P1 & P2 projects and FE Team on the design Working in RFQ’s of DMF & Clutches & checking the design feasibility.

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience