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7.0 - 12.0 years
6 - 8 Lacs
Ahmedabad
Work from Office
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...
Posted 3 months ago
3.0 - 8.0 years
3 - 8 Lacs
Nalagarh
Work from Office
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...
Posted 3 months ago
14.0 - 24.0 years
16 - 31 Lacs
Gadag
Work from Office
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,...
Posted 3 months ago
4.0 - 9.0 years
5 - 12 Lacs
Hyderabad/Secunderabad
Work from Office
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...
Posted 3 months ago
12.0 - 20.0 years
2 - 3 Lacs
Gurugram
Work from Office
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
Posted 3 months ago
2.0 - 6.0 years
2 - 6 Lacs
Ahmedabad
Work from Office
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...
Posted 3 months ago
2.0 - 4.0 years
0 - 0 Lacs
Hyderabad
Work from Office
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 ...
Posted 3 months ago
3.0 - 8.0 years
4 - 8 Lacs
Navi Mumbai
Work from Office
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...
Posted 3 months ago
8.0 - 13.0 years
8 - 15 Lacs
Mahad, Mumbai (All Areas)
Work from Office
•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.
Posted 3 months ago
17.0 - 27.0 years
27 - 42 Lacs
Nagpur
Work from Office
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...
Posted 3 months ago
15.0 - 24.0 years
18 - 30 Lacs
Banas Kantha, Gurugram, Jaipur
Work from Office
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...
Posted 3 months ago
3.0 - 5.0 years
2 - 5 Lacs
Akola
Work from Office
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...
Posted 3 months ago
5.0 - 10.0 years
3 - 8 Lacs
Halol
Work from Office
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.
Posted 3 months ago
8.0 - 10.0 years
8 - 9 Lacs
Rajkot
Work from Office
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...
Posted 3 months ago
12.0 - 20.0 years
12 - 20 Lacs
Mumbai
Work from Office
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...
Posted 3 months ago
3.0 - 5.0 years
3 - 6 Lacs
Mumbai, Mumbai Suburban
Work from Office
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...
Posted 3 months ago
10.0 - 15.0 years
7 - 8 Lacs
Mumbai
Work from Office
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
Posted 3 months ago
8.0 - 13.0 years
8 - 10 Lacs
Ankleshwar
Work from Office
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 .
Posted 3 months ago
3.0 - 8.0 years
4 - 9 Lacs
Panchkula
Work from Office
Role & responsibilities 1. Regulatory Submissions and Approvals: Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements. Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for regulatory submissions. Liaise with regulatory authorities and consultants in these regions to facilitate product approvals and resolve any queries or deficiencies. 2. Compliance and Documentation: Ensure compliance with local regulatory requirements, guidelines, and international standards (such as WHO, ICH, or country-specific regulati...
Posted 3 months ago
3.0 - 5.0 years
3 - 4 Lacs
Navi Mumbai
Work from Office
Role & responsibilities Contractual Role for 6 Months. Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages....
Posted 4 months ago
2.0 - 5.0 years
8 - 13 Lacs
Mangaluru
Work from Office
We are looking for a highly skilled and experienced Customer Service Executive to join our team in Mangalore. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supe...
Posted 4 months ago
2.0 - 5.0 years
8 - 13 Lacs
Mumbai
Work from Office
We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bilaspur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of t...
Posted 4 months ago
1.0 - 3.0 years
8 - 13 Lacs
Mumbai
Work from Office
We are looking for a highly skilled and experienced Customer Service Executive to join our team in Surat. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...
Posted 4 months ago
1.0 - 6.0 years
8 - 13 Lacs
Mumbai
Work from Office
We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1 to 6 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Sup...
Posted 4 months ago
2.0 - 5.0 years
8 - 13 Lacs
Hubli
Work from Office
We are looking for a highly skilled and experienced Customer Service Executive to join our team in Hubli. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...
Posted 4 months ago
 
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