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3.0 - 8.0 years
0 - 1 Lacs
Bengaluru
Work from Office
Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia, the Middle East, and the rest of Asia-Pacific. Recognized by Great Place to Work in India, Chile, Romania, the US, and the UK in 2022, we offer a dynamic, growth-oriented, and meritocracy-based culture that prioritizes continuous learning and skill development, work-life balance, and equal opportunity for all. Curious to know what its like to work at Evalueserve? Read on. About Investment Research (IR) As a global leader in knowledge processes, research, and analytics, youll be working with a team that specializes in global market research, working with the top-rated investment research organizations, bulge bracket investment banks, and leading asset managers. We cater to 8 of the top 10 global banks, working alongside their product and sector teams, supporting them on deal origination, execution, valuation, and transaction advisory-related projects. What you will be doing at Evalueserve Work directlywith the head of the team, who has been consistently ranked as the top analystin CEEMEA strategy by several top-tier investment banks. Handle research, strategy, and analytics for all EM fixed income-related products offered by theresearch platform of the banking client. Conduct macroeconomicand market research across emerging markets. Develop andmaintain financial models and analytical frameworks for EM fixed incomeproducts. Analyze largedatasets to identify market trends and investment opportunities. Support theteam in producing high-quality research reports and market commentary. Collaboratewith trading, sales, and risk teams to align strategy insights with businessneeds. Utilize toolssuch as Bloomberg, Macrobond, and Haver, and IMF databases for data extractionand analysis. What were looking for: Advanceddegree in economics /statistics /engineering with minimum relevant experienceof 3 years. Progress towards CFA / FRM is preferable. Priorexperience of macro research, financial modeling, structuring, trading, ormarket risk management Keen interestin global financial markets and knowledge of recent developments. Strongquantitative and mathematical skills with experience of working with largeamounts of data. AdvancedExcel, VBA analytical skills, and knowledge of basic econometrics is a must.Working knowledge of Python or R will be considered a plus. Excellentwritten and verbal communication skills ability to write research reports andcomment on market developments. Knowledge ofdatabase tools Bloomberg, Macrobond, Haver, World Bank, IMF, etc. Follow us on https://www.linkedin.com/compan y/evalueserve/ Click here to learn more about what our Leaders talking on achievements AI-powered supply chain optimization solution built on Google Cloud. How Evalueserve is now Leveraging NVIDIA NIM to enhance our AI and digital transformation solutions and to accelerate AI Capabilities . Know more about how Evalueserve has climbed 16 places on the 50 Best Firms for Data Scientists in 2024! Want to learn more about our culture and what its like to work with us? Write to us at: careers@evalueserve.com Disclaimer: The following job description serves as an informative reference for the tasks you may be required to perform. However, it does not constitute an integral component of your employment agreement and is subject to periodic modifications to align with evolving circumstances. Please Note: We appreciate the accuracy and authenticity of the information you provide, as it plays a key role in your candidacy. As part of the Background Verification Process, we verify your employment, education, and personal details. Please ensure all information is factual and submitted on time. For any assistance, your TA SPOC is available to support you.
Posted 2 days ago
2.0 - 5.0 years
7 - 11 Lacs
Hyderabad
Work from Office
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 Servers and User Admin Management for different environments, ensuring data is stored and retrieved efficiently, and safeguarding sensitive information and ensuring the uptime, performance, and security of IT infrastructure & Software maintenance, We are seeking a skilled BI Platform Administrator to manage, maintain, and optimize our enterprise Power BI and Tableau platforms The ideal candidate will ensure seamless performance, governance, user access, platform upgrades, troubleshooting, and best practices across our BI environments, Roles & Responsibilities: Administer and maintain Power BI Service, Power BI Report Server, and Tableau Server/Online/any Cloud platforms (AWS, Azure/GCP) Preferred AWS Cloud experience, Configure, monitor, and optimize performance, capacity, and availability of BI platforms, Set up and manage user roles, permissions, and security policies, Manage BI platform upgrades, patches, and migrations, Monitor scheduled data refreshes and troubleshoot failures, Implement governance frameworks to ensure compliance with data policies, Collaborate with BI developers, data engineers, and business users for efficient platform usage, Automate routine administrative tasks using scripts (PowerShell, Python, etc), Create and maintain documentation of configurations and operational procedures, Install, configure, and maintain BI tools on different operating systems, servers, and applications to ensure their reliability and performance Monitor Platform performance and uptime, addressing any issues that arise promptly to prevent service interruptions Implement and maintain security measures to protect Platforms from unauthorized access, vulnerabilities, and other threats Manage backup procedures and ensure data is securely backed up and recoverable in case of system failures Provide technical support to users, troubleshooting and resolving issues related to system access, performance, and software Apply operating system updates, patches, and configuration changes as necessary Maintain detailed documentation of Platform configurations, procedures, and change management Work closely with network administrators, database administrators, and other IT professionals to ensure that Platforms are integrated and functioning optimally Install, configure, and maintain database management Platforms (BI), ensuring services are reliable and perform optimally Monitor and optimize database performance, including query tuning, indexing, and resource allocation Maintain detailed documentation of Platform configurations, procedures, and policies Work closely with developers, Date Engineers, system administrators, and other IT staff to support database-related needs and ensure optimal platform performance Basic Qualifications and Experience: Over all 3+ years of experience in maintaining Administration on BI Platforms is preferred, 3+ years of experience administering Power BI Service and/or Power BI Report Server, 2+ years of experience administering Tableau Server or Tableau Cloud, Strong knowledge of Active Directory, SSO/SAML, and Role-Based Access Control (RBAC), Experience with platform monitoring and troubleshooting (Power BI Gateway logs, Tableau logs, etc), Scripting experience ( e-g , PowerShell, DAX, or Python) for automation and monitoring, Strong understanding of data governance, row-level security, and compliance practices, Experience working with enterprise data sources (SQL Server, Snowflake, Oracle, etc), Familiarity with capacity planning, load balancing, and scaling strategies for BI tools, Functional Skills: Should Have: Knowledge of Power BI Premium Capacity Management and Tableau Resource Management, Experience integrating BI platforms with CI/CD pipelines and DevOps tools, Hands-on experience in user adoption tracking, audit logging, and license management, Ability to conduct health checks and implement performance tuning recommendations, Understanding of multi-tenant environments or large-scale deployments, Good to Have: Experience with Power BI REST API or Tableau REST API for automation, Familiarity with AWS Services and/or AWS equivalents, Background in data visualization or report development for better user collaboration, Exposure to other BI tools ( e-g , Looker, Qlik, MicroStrategy), Knowledge of ITIL practices or experience working in a ticket-based support environment, Experience in a regulated industry (finance, healthcare, etc) with strong compliance requirements, Education & Experience : Masters degree with 2-3+ years of experience in Business, Engineering, IT or related field OR Bachelors degree with 5-6+ years of experience in Business, Engineering, IT or related field OR Diploma with 8+ years of experience in Business, Engineering, IT or related field Soft Skills: Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule Candidates must be willing and able to work during evening or night shifts, as required based on business requirements, EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment Please contact us to request an accommodation, Ready to Apply for the Job We highly recommend utilizing Workday's robust Career Profile feature to complete the application process A link to update your profile is available when you click Apply You can then complete your Workday profile in minutes with the ?Upload My Experience? functionality to upload an updated copy of your resume or you can simply edit the individual sections of your Career Profile, Please note that you should be in your current position for at least 18 months before applying to internal positions Staff must notify their current manager if invited for an interview In addition, Staff are ineligible to apply for open positions if (a) their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document or (b) their most recent performance rating was not a ?Partially Meets Expectations? or higher Please visit our Internal Transfer Guidelines for more detailed information GCF Level GCF Level 04 Career Category Engineering Position Type Full time Show
Posted 2 days ago
8.0 - 10.0 years
8 - 10 Lacs
Tumkur, Chikkaballapura, Ramanagara
Work from Office
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 any issues. Preferred candidate profile Perks and benefits
Posted 3 days ago
5.0 - 10.0 years
3 - 6 Lacs
Andhra Pradesh
Work from Office
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 requirements. 7. ROW engineers monitor progress, track milestones, and provide regular updates on land acquisition activities to project stakeholders, management, and regulatory agencies. They may also prepare reports documenting compliance with project requirements and regulations.
Posted 3 days ago
5.0 - 8.0 years
12 - 17 Lacs
Thane, Navi Mumbai, Mumbai (All Areas)
Work from Office
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 maintain compliance. Provide regulatory insights to internal teams on best practices for data management and documentation. 4. Documentation and Record Keeping: Maintain well-organized records of submissions, communications, and approvals. Use regulatory software and systems for document tracking, version control, and report generation. Education: 5 - 8 years of experience in regulatory affairs, focusing on Asian markets. Desirable Skills & Competencies: Attention to Detail: Ability to review and analyze technical documentation with precision. Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams. Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges. Proficient in MS Office and regulatory documentation software. Interested candidates can apply or mail your resume. If you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com
Posted 5 days ago
5.0 - 10.0 years
6 - 10 Lacs
Kolkata
Work from Office
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 aware of new products and competition status
Posted 6 days ago
4.0 - 8.0 years
5 - 9 Lacs
Dholka
Work from Office
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: Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline. 6. Preparation of COPPs (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals. 7. Preparation of Tender documents. 8. Support for activities of contract manufacturing product Preferred candidate profile Must have experience in Pharmaceuticals Industries
Posted 1 week ago
11.0 - 17.0 years
9 - 13 Lacs
Ahmedabad
Work from Office
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 analysis, and submission readiness. 4. Liaise with regulatory authorities including (EU, CIS, LATAM, ROW, Asia) and others. 5.Develop and implement regulatory strategies across international markets (EU, CIS, LATAM, ROW, Asia, Middle East, and Georgia) to ensure timely submissions and approvals for product registrations and lifecycle maintenance. 6. Lead the preparation, review, and submission of CTD/eCTD/ACTD dossiers for multiple dosage forms including solid orals, injectables, topicals, and liquids for pharmaceutical and nutraceutical products, as per country-specific guidelines. 7.Manage lifecycle regulatory activities such as renewals, variations, line extensions, and prompt responses to health authority queries across global jurisdictions. 8.Maintain up-to-date knowledge of global regulatory and provide strategic recommendations based on updated guidelines and country-specific requirements. 9.Ensure regulatory compliance for labeling, artworks, inserts, and packaging as per regional regulations and internal quality standards. 10 .Support and participate in regulatory audits and inspections by ensuring the availability of complete and updated documentation and responses. 11.Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. Preferred candidate profile
Posted 1 week ago
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 regulatory and code of conduct requirements; 7.Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. 8.Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. 9. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap analysis, and submission readiness. 10. Lead and train junior regulatory staff, encourage cross-market knowledge transfer, and ensure consistent alignment with global regulatory processes and corporate objectives. .
Posted 1 week 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 consultants and agents for submissions and queries. Product Lifecycle Management: Manage variations, renewals, query responses, and product registration maintenance. Handle change control and post-approval regulatory activities. Document Control: Maintain updated regulatory records and submission trackers. Ensure timely and organized archiving of all submitted dossiers and correspondence.
Posted 1 week 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, ensuring adherence to project specifications, timelines, and budgets. 3- Infrastructure Development: Manage the development of civil infrastructure, including access roads, drainage systems, and other necessary components. Coordinate with construction teams to ensure infrastructure development aligns with project timelines. 4- Permitting and Compliance: Work closely with regulatory authorities to secure necessary permits for civil construction activities. Ensure compliance with local, state, and federal regulations related to civil engineering and construction. 5- Quality Assurance: Implement quality control processes to ensure that civil engineering components meet industry standards and project specifications. Conduct regular inspections and audits to verify compliance with quality requirements. 6- ESG Compliance: Understand & Implement ESMS policies and guidelines. Implement and enforce safety protocols on-site, ensuring compliance with industry standards and regulations. Conduct regular safety audits and address any civil engineering safety concerns promptly. 7- Documentation and reporting: Create and maintain comprehensive documentation of civil engineering as built drawings, construction activities, and quality assurance processes. Prepare reports and updates for project managers and stakeholders. 8- Team Collaboration: Collaborate with cross-functional teams, including project managers, electrical engineers, and other stakeholders, to ensure coordinated project execution. Provide technical guidance and support to team members.
Posted 1 week 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 received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits
Posted 1 week 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 1 week 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 products and competition status
Posted 1 week 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 Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable
Posted 2 weeks 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 have exposure to in-licensed dossier filing and out licensing
Posted 2 weeks 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 2 weeks 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 new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com
Posted 2 weeks 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 dispute resolutions. Coordinate with survey teams, consultants, and local agencies for land demarcation and feasibility assessments. Regulatory & Legal Compliance Ensure compliance with state and central land acquisition policies, environmental regulations, and power sector norms. Assist in securing statutory clearances including transmission line permissions, substation land permits, and solar project approvals. Documentation & Reporting Maintain comprehensive records of land acquisition processes including agreements, MoUs, payments, and correspondences. Provide regular updates and reports on land acquisition status, challenges, and milestones to senior management.
Posted 3 weeks 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 and commercialization. 8. Conduct training sessions on regulatory updates and internal System 9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations. 10. Support internal and external audits by providing required regulatory documents and justifications. 11. Guide and review work of junior team members or trainees. 12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates. 13. Review of all dossiers related technical documents Preferred candidate profile Experience in reviewing of Analytical documents
Posted 3 weeks 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 weeks 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 products and competition status
Posted 3 weeks 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 company products for quality representation, and work in the field to meat doctors, pharmacists, and KOLs for promoting products and doing market research and Co-ordinate with KOL . 6 You will search analyse & add new products in existing country and Tender opportunities within the assigned territories in ROW Market. Preferred candidate profile 1. B. Pharma or B.Sc and MBA in Marketing, 12+ years in Pharma International Sales & Business development in Nutraceuticals Formulation in ROW Market 2. You should have good knowledge of developing new markets, Implementing strategy in ROW Market for promoting Nutraceuticals formulation. 3. You should be good in Good Negotiation skills and Good Commercial acumen. 4.You will be responsible for identifying & registering Nutraceuticals products , handling imports & logistics & dealing with dealers, distributors & collection of products from ROW Countries. 5. You should also be good in Communication, coordination with all the stakeholders, Teamwork, Problem solving.etc. 6. You will co-ordinate with medical and sales team for launching new products and training to field force. 7. Candidate should have traveled extensively across ROW countries (Pharma industry only)& promoting pharma Neutraceutcals.
Posted 3 weeks 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 country sales managers on regulatory requirements. Provide strategic advice to senior management throughout the development of a new product. Manage teams of colleagues involved with the development of new products. Undertake and manage regulatory internal audits .. Review company practices and provide advice on changes to systems. Liaise with, and make presentations to, regulatory authorities. Follow up with marketing team for marketing authorization, registration data and status. Take part in the development of marketing concepts and approve packaging and advertising before a product's release. Experience in Dossier. Preferred candidate profile Qualification required: Graduate in Pharmacy/ Science Post graduate in Pharmacy/ Science Experience required: 04 to 06 years in preparing dossiers for ROW market. Should be experienced in preparing country specific dossiers. Well versed with country specific guidelines. Fluent in communication. Candidate should be living around Andheri or should be comfortable travelling to Andheri (E).
Posted 3 weeks 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 weeks ago
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