167 Row Jobs - Page 4

Role Name: BI Platform Automation Engineer Job Type: Full-time About Amgen Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples lives easier, fuller and longer We discover, develop, manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 45 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond whats known today, About The Role Role Description: The role is responsible for performance monitoring, maintenance, and reliable operation of BI Platforms, BI servers and database This role involves managing BI Ser...

Role & responsibilities To identify, Negotiation and acquisition of cost effective and business doable properties for organization in respect of solar installations. To obtain permissions & licenses from Govt. and other authorities for the development of solar installation. Identification & negotiation for financially & technically feasible & cost saving properties with the help of RoI and other calculations. Negotiation for rental restructuring with existing property owners. Negotiation on renewal cost. To maintain healthy relationship with Govt. official, local politicians, civilians & residents to avoid unwanted resistances and agitations. To ensure smooth development of project without a...

Role & responsibilities 1. To maintain detailed records of land acquisitions, easements, permits, agreements, and other relevant documents throughout the project lifecycle. This documentation is critical for legal compliance, project monitoring, and future maintenance. 2. To discuss with Local Farmers & resolving ROW. 3. Coordinating with Revenue Officers/ Agricultural Officers for Crop Yield Prices. 4. Discussing with Collectors/Police Deptt. for their intervention in resolving critical ROW's. 5. Handing over crop compensation cheques to eligible farmers duly taking acknowledgements. 6. Collaborate closely with other members of the project team. to ensure alignment of project goals and requ...

We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to...

Incoda Media is looking for Assistance Manager / Manager - Media Sales to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully a...

Role : Senior Executive Qualification: M. Pharma/B. Pharma Experience : 4 to 8 Years Location : Dholka, Gujarat Responsibilities 1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Subm...

Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap ...

1.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 Latam and CIS , ROW Countries and other country as per company requirements. 2.Responsible for final review of dossier before submission. 3.To coordinate with technical team for documents required for dossier. 4.Responsible to gather data related for dossier through online sources, laboratories, manufactures etc. 5.Reviewing artwork for products as per relevant regulatory authority requirements. 6.To verify the text matter, including text for product information leaflets and labels for medicines in accordance with the re...

Key Responsibilities: Dossier Compilation: Prepare, compile, and review regulatory submissions (CTD/ACTD format) for ROW & emerging markets. Work on Module 1 (administrative/legal), Module 2 (summaries), and Module 3 (quality) for OSD products. Ensure dossier accuracy, completeness, and alignment with country-specific requirements. Regulatory Compliance: Ensure all documentation complies with ICH , WHO , and respective country-specific guidelines . Maintain awareness of evolving regulatory requirements across ROW markets. Coordination & Liaison: Coordinate with internal teams: QA, QC, Production, Packaging, and F&D for data collation. Liaise with external stakeholders like regulatory consult...

Lead - Civil Construction at (Project Site) Job Summary Managing site preparation, and Civil infrastructure development for wind energy installations. The Civil Lead collaborates with cross-functional teams to ensure the successful implementation of civil engineering components, Compliance with industry standards, and the overall success of Renewable energy projects. Core Responsibilities 1- Site Assessment and Preparation: Conduct site assessments to evaluate the feasibility of renewable energy projects from a civil engineering perspective. Oversee site preparation activities, including grading, excavation, and land clearing.. 2- Contractor Management: Manage relationships with contractors,...

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...

1. Transmission Line route finalisation, as per CEA Guideline 2. Detailed Survey and preparation of Profile, SLD and Tower Schedule 3. Optimisation of Route length, to minimise Quantity, ROW & Statutory Approvals 4. Ensure sec 68 Approval from MOP & CEA 5. Filing of Sec 164, PTCC & Statutory approval 6. Coordination with site team for Final CEIG / CEA Approval

NKP Pharma is looking for EXECUTIVE / ASSISTANT MANAGER (SALES) to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new...

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development ...

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Get feedback from all the countries for respective variation, and their timely submission. 7. renewals. 8. Master data Updating. 9. Follow ups with plant for documentation regularly and review meeting. Preferred candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products Must hav...

•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.

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for ne...

Land Acquisition & ROW Management Identify, evaluate, and acquire land parcels for solar project development and T&D corridors. Coordinate with local authorities, landowners, and government departments to ensure smooth land acquisition. Manage Right of Way (ROW) approvals for T&D lines, including negotiation and conflict resolution with landowners and stakeholders. Secure necessary legal documentation including title verification, land conversion, and registration. Stakeholder & Liaison Management Build and maintain relationships with government bodies (Revenue, Forest, Electricity Boards), local landowners, and communities. Liaise with legal teams for risk assessment, litigation checks, and...

Role & responsibilities 1. Prepare, compile, and review regulatory dossiers for submission. 2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams. 3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions. 4. Maintain regulatory files and track submission and approval status using internal systems. 5. Provide regulatory input during product development, scale-up, and lifecycle management. 6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations. 7. Ensure products comply with all regulatory requirements through each stage of development an...

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Apollo Pipes Ltd is looking for Area Sales Manager - Rajkot to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new pro...

Role & responsibilities 1. Candidate will be based at Mumbai and responsible for handling International Business Development for Pharma formulations in Nutraceuticals Formulation for entire ROW Market. 2. You will be responsible for Promoting Nutraceuticals Formulation products to gain maximum market share with responsibility. 3.You will be responsible for identifying & registering new products, handling imports logistics & dealing with dealers, distributors &collection of payments. 4. You will out late business across new geographies in ROW by strategically shortlisting products/partners and business models for Nutraceutcals Products. 5. You will train field force and business partners on c...

Position: Regulatory Affairs Executive Location: Andheri (E) Role & responsibilities Ensure that the company's products comply with the regulations of the regions where they are distributed. Keep up to date with national and international legislation, guidelines and customer practices. Prepare dossiers, documents and samples as per requirement of markets for participation in tenders. Collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats. Monitor and set timelines for registrations variations and renewal approvals and submissions. Write clear, accessible product labels and patient information leaflets. Advise c...

To prepare the Registration and Renewal dossiers in CTD, ACTD & Country Specific format To prepare the dossiers for allotted countries Timely answering the queries EXP in ROW market B. Pharm, M.Pharm,Science graduate/PG Required Candidate profile Exp as Head of department for ROW-Regulatory affairs Exp in Team handling kindly send resume to hr1@flamingopharma.com,sunil@flamingopharmacom

Job Description: Regulatory Affairs Assistant Manager / Manager Injectable & OSD Facility Department: Regulatory Affairs Location: GIDC Ankleshwar Key Responsibilities: Prepare and submit dossiers (CTD/ACTD) for ROW & US markets. Ensure compliance with local regulatory guidelines and GMP standards. Liaise with regulatory agencies and respond to queries promptly. Manage product registrations, renewals, and variations. Monitor regulatory updates and ensure adherence to changes. Support quality audits and review labeling/artwork for compliance .