354 Dmf Jobs - Page 13

Designation : Executive / Sr Executive Department : Regulatory Affairs (API Industry only ) Qualification :M.Sc in Chemistry. Experience: 3 to 6 years. CTC : Rs 5 lacs to 7 lacs. Key Skills: DMF, NDA / ANDA dossiers, Regulatory Affairs. Filing of new Drug Master Files (DMFs) / Dossiers to respective countries (US, Europe, EDQM, Japan ) by compiling the documents as per CTD requirements. To interact and coordinate with R&T and manufacturing sites for all regulatory submissions (New filing and Amendments) and customer requirements. Maintaining life cycle of products as per the respective region wise requirements. Submission of Applicant Part to customers as per the requirement. Candidates work...

•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.

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/pape...

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/pape...

Role & responsibilities - Preparing Dossiers for registration of products in various ROW markets - Knowledge of CTD format is mandatory Preferred profile Qualification: B. Pharm and M. Pharm Experience: 2 years Salary: 20,000 to 40,000 per month Health insurance Accidental insurance Annual bonus

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About Team The Statutory Audit Team is responsible for ensuring the accuracy and compliance of our company's financial statements with relevant laws and regulations. This team conducts thorough audits to identify areas of improvement, mitigate risks, and provide assurance on the financial health of the organization. With expertise in financial reporting, ...

Prepare and submit regulatory documents for product approvals, renewals, variations, and notifications. Maintain up-to-date knowledge of regulatory guidelines. Dossier preparation. Support product registration processes. Required Candidate profile 1–3 years of experience in regulatory affairs. Qualification : BSC / MSC / B Pharm Office Location : Mulund

Preparation and Compilation of DMF's in-line with regulations of Regulatory and Semi-Regulatory countries. Supporting to the concerned Marketing department/team's in terms of providing appropriate documents. Coordinating effectively with all cross functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of API DMFs. Attending calls/Meetings with marketing teams, customers and plants regarding regulatory related issues as and when required. Development of DMF's for registration of products in countries like Brazil, China, Russia markets. Collecting, collating and evaluating scientific data received from plant/R&D. Responsibl...

Regulatory Strategy & Planning Submissions & Approvals Team Leadership & Governance Global Compliance & Maintenance Cross-Functional Collaboration External Stakeholder Management

1. Preparation and review of Drug Master Files, Dossiers as per regulatory guidelines. 2. Ensuring compliance with regulations set by the authorities. 3. Keeping up to date with changes in regulatory legislation and guidelines. 4. Analyzing complicated information & data provided by other departments, including trial data. 5. Ensuring that quality standards are met and submissions meet strict timelines. 6. Coordination with QA, QC & R&D to get documentation required for preparation of Drug Master Files & Technical dossiers. 7. Responsible for DMF/Dossier updations, revisions. 8. Responding to Customers and Regulatory Authorities on technical queries in time. 9. Maintaining customer correspon...

Role & responsibilities Regulatory Strategies & Submissions: Develop & implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and the business needs. Preparing and submitting regulatory documents like Drug Master Files (DMFs) and marketing authorization applications (MAAs) to regulatory bodies. Preparation and Compilation of dossiers in CTD & eCTD. Collaborating with cross-functional teams to address regulatory queries in a timely manner. Responsible for end-to-end filing of New products (Actives / Fixed Dose Combinations / Nutritional supplements etc.) in CDSCO (Central Drugs Standard Control Organization), FSSAI, State FDA and other re...

Urgent Requirement For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 13 to 23 years of experience in FML Regulatory Affairs Job Title: Deputy Manager / Manager / Senior Manager / AGM Experience: 13 to 23 years in FML RA field Candidates Only. Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Markets : China, Europe, Australia, US, ROW Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities International Pr...

We are hiring for multiple roles in the QC Department! Join us at Global Calcium Pvt. Ltd. a leading pharmaceutical manufacturer, and be part of a growing team committed to quality and innovation. Open Positions (Multiple Vacancies): QC ICP-MS Analyst (2 openings) Hands-on experience with ICP-MS instrumentation Knowledge of elemental impurity analysis and related regulatory guidelines QC – DMF Support (2 openings) Exposure to DMF preparation, review & support documents Understanding of regulatory documentation and compliance standards QC – Analytical Validation Support (2 openings) Knowledge of method validation techniques (HPLC/GC/UV) Experience in handling validation protocols and reports ...

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs.

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site...

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. 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. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6...

Role & responsibilities We are hiring for the role of Executive - Regulatory Affairs department (API Industry ) Preferred candidate profile Candidate with 3 to 6 years experience in the Regulatory Affairs (API Industry) can apply for the job . Please drop relevant cvs to ramya_n@hikal.com

Dossier Power House

Urgent job opening for Senior Quality Assurance Executive at Dombivli. Qualification : B.Sc., M.Sc. Experience : 6 to 8 years Description of Job Responsibilities 1) Responsible for Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA. 2) Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc. 3) Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees. 4) To evaluate Quality and stability of finished ...

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...

Role & responsibilities 1. Preparation of DMFs for regulated (US, EU) & ROW markets. 2. Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs. 3. Preparation of response to deficiencies from regulatory authorities & customers. 4. Review of the data for DMF preparation received from mfg. site and R&D and ensuring required corrections. 5. Coordination with cross functional teams for data / documents. Review of the DMFs & other submissions prepared by the team. Preferred candidate profile 1. Candidate should be M.Sc. Chemistry with 6-8 years experience OR B.Sc. - Chemistry with 8 years plus relevant work experience in a reputed pharma industry, preferably i...

Dear Candidate, We have a Job Opening for FLO-ETP /WTP in Reputed Industry at Harihar, Karnataka. Requirement Details: Location : Harihar, Karnataka Designation: Assistant Manager/Engineer Experience: 3 to 7 Years Qualification: BE /B. Tech Chemical Engineering Regular Expected Notice Period : Immediate to 30 days Responsibilities: Ensure supply of Filter, DM and Soft water to Pulp plant, fibre plant, Energy Centre and Colony Achieving First Pass Yield (FPY) and Up time (UT) Ensure treatment of effluent If you are interested, kindly share your updated CV to cg12@convate.com with below details. Kindly fill the below details: 1. Reason for job change: 2. Current Salary: 3. Expected Salary: 4. ...

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. Lead, manage and develop leading edge regulatory strategies leading to successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required data packages and facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development activities to provide appropriate CMC as well as regulatory strategies. ...