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1.0 - 3.0 years

0 - 3 Lacs

noida

Work from Office

1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timely entries of submissions / dispatches Qualifications :- A bachelors degree in B. Pharma Experienced with 1 year Should apply. Excellent communication skills Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management Contact No- 8810226562

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17.0 - 27.0 years

20 - 30 Lacs

nagpur

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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

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3.0 - 5.0 years

3 - 4 Lacs

navi mumbai

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Role & responsibilities 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. Preparation and submission of Query response raised by the Health Authority. To undertake any other assignment given by superior of the department / management from time to time. To support in documentation in national and international tenders. Management of Product Database. Archival of dossier. For COPP Application- Support with documents. Preferred candidate profile Must be from Formulation background interested applicant can send CV on shital@mjbiopharm.com , janhavi.shedekar@mjbiopharm.com or contact on 9867700982. Perks and benefits

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10.0 - 15.0 years

10 - 15 Lacs

hyderabad

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Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority

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14.0 - 18.0 years

11 - 21 Lacs

bengaluru

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We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa. • Support product registrations, renewals & variations. • Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management. • Respond to health authority queries in coordination with CMC, clinical, and quality teams. • Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines. • Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc. • Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines. • Experience working with local affiliates or partner companies in Emerging Markets. • Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc. • Experience with regional electronic submission platforms. Qualifications: • Bachelors or Masters degree in Life Sciences, Pharmacy, Biotechnology, or related field. • Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets. • Knowledge of CTD structure, Module 1 customization, and regional submission formats. • Strong project management, communication, and stakeholder coordination skills

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3.0 - 8.0 years

2 - 5 Lacs

visakhapatnam, hyderabad

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Diploma/Bachelor’s degree in Electronics, Telecommunications, Electrical, or Civil Engineering. 4–8 years of experience in fiber deployment, with at least 2–3 years in a supervisory/cluster-level role. Mail - hr.ta@depl.co.in Andhra Pradesh

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5.0 - 10.0 years

3 - 8 Lacs

ahmedabad

Work from Office

Key Responsibilities Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions Manage product registration, renewals, variations, and post-approval compliance Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines Coordinate bioequivalence studies and relevant documentation Review technical files and maintain up-to-date regulatory documentation Liaise with regulatory authorities, internal departments, and external partners Mentor junior RA team members and drive process improvements Requirements B.Pharm / M.Pharm / Life Sciences background Minimum 6 years experience in Regulatory Affairs within the pharmaceutical industry Proficient in CTD/ACTD/eCTD dossier compilation Experience with parenteral dossiers (preferred) Exposure to global regulatory submissions and product lifecycle management Proficient in MS Office, with strong communication and leadership skills

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4.0 - 9.0 years

5 - 9 Lacs

thane

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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

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7.0 - 11.0 years

8 - 12 Lacs

pune

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Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory strategies to ensure compliance with international and regional regulations . Prepare, review, and submit regulatory documents in line with global requirements (US, EU, and emerging markets). Liaise with regulatory authorities to address queries and obtain timely approvals. Monitor evolving regulatory guidelines and industry trends , assessing their impact on product development and commercialization. Partner with R&D, Quality, Clinical, and Legal teams to provide regulatory insights throughout the product lifecycle. Support documentation for clinical trials , including protocols, investigator brochures, and informed consent forms. Conduct risk assessments and provide recommendations for safety reporting and compliance obligations. Participate in audits and inspections , driving corrective and preventive actions as needed. Provide regulatory training and guidance to internal stakeholders to enhance compliance awareness. Qualifications & Requirements Education: Bachelor’s degree in Pharmacy or a related scientific field (Master’s preferred). Experience: 7 - 8 years in pharmaceutical regulatory affairs within a global organization. Strong knowledge of FDA regulations (21 CFR Part 11), ICH guidelines, EMA, and regional market requirements . Demonstrated success in regulatory submissions leading to product approvals. Proven project management skills , with the ability to manage multiple projects in a dynamic environment. Excellent written and verbal communication skills for engaging internal teams and external authorities. Strong analytical, problem-solving, and decision-making abilities. Proficiency in regulatory information management systems and related tools.

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1.0 - 7.0 years

25 - 30 Lacs

kolkata, new delhi

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Perpetuity Capital is looking for AREA SALES MANAGER 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

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3.0 - 5.0 years

4 - 5 Lacs

jaipur, jaisalmer, jodhpur

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We are looking for Right of Way (ROW) and Lead land acquisition processes for high voltage transmission projects. Handle negotiations, legal documentation, govt. clearances, and stakeholder management to ensure smooth and timely project execution.

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5.0 - 10.0 years

4 - 5 Lacs

mumbai suburban, mumbai (all areas)

Work from Office

Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with other team members to help with the process. Preferred candidate profile : Reputed Pharma background only

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5.0 - 10.0 years

20 - 27 Lacs

noida

Work from Office

Description: Power BI with Fabric Requirements: Job Duties Design, develop, and maintain Power BI reports and dashboards that provide actionable insights from assessment data Work with data provided by Organization's established ETL processes and other data sources Create and optimize data models within Power BI to ensure reports are accurate and performant Apply innovative visualization techniques to clearly communicate assessment analytics Deploy and maintain Power BI reports in a Microsoft Fabric environment Collaborate with product management to prioritize and plan necessary delivery, design improvements and performance. Collaborate with the product team and development community of practice to review and discuss new analytics and reporting technologies. Work with subject matter experts to understand data context and reporting requirements Maintain technical documentation and source control related to project design and implementation. QUALIFICATIONS Bachelor’s degree in computer science, analytics or a related field or related work experience. Minimum of 5 years experience working with Power BI and Power Query with databases and loading from files in Azure and SharePoint. Experience consuming data from various sources including SQL databases, Azure storage, and SharePoint Strong DAX skills with ability to write complex calculations including statistical operations and ranking functions Excellent understanding of data modelling including star and snowflake schema and use of fact and dimension tables. Demonstrable experience implementing row-level security and dynamic row-level security in Power BI reports Experience with Power BI report performance optimization techniques Familiarity with Microsoft Fabric and Power BI deployment processes Practical experience with Azure SQL (or similar databases) for data exploration and validation Experience with Power BI Desktop and Power BI Service Excellent communication skills, both verbal and written. Excellent numerical skills including some knowledge of statistics Understanding of data protection principles Comfortable working with staff at all levels. Ability to self-organise, prioritise and track tasks. PREFERRED QUALIFICATIONS Experience in using Python or R for analysis and incorporating into Power BI visualisations. Familiarity with advanced charting technologies such as Deneb, SVG or D3.js ideal. Familiarity with assessment data and psychometric principles Experience with Azure is a plus. Experience with Agile development practices (Scrum or Kanban) is a plus. Job Responsibilities: Job Duties Design, develop, and maintain Power BI reports and dashboards that provide actionable insights from assessment data Work with data provided by organization's established ETL processes and other data sources Create and optimize data models within Power BI to ensure reports are accurate and performant Apply innovative visualization techniques to clearly communicate assessment analytics Deploy and maintain Power BI reports in a Microsoft Fabric environment Collaborate with product management to prioritize and plan necessary delivery, design improvements and performance. Collaborate with the product team and development community of practice to review and discuss new analytics and reporting technologies. Work with subject matter experts to understand data context and reporting requirements Maintain technical documentation and source control related to project design and implementation. QUALIFICATIONS Bachelor’s degree in computer science, analytics or a related field or related work experience. Minimum of 5 years experience working with Power BI and Power Query with databases and loading from files in Azure and SharePoint. Experience consuming data from various sources including SQL databases, Azure storage, and SharePoint Strong DAX skills with ability to write complex calculations including statistical operations and ranking functions Excellent understanding of data modelling including star and snowflake schema and use of fact and dimension tables. Demonstrable experience implementing row-level security and dynamic row-level security in Power BI reports Experience with Power BI report performance optimization techniques Familiarity with Microsoft Fabric and Power BI deployment processes Practical experience with Azure SQL (or similar databases) for data exploration and validation Experience with Power BI Desktop and Power BI Service Excellent communication skills, both verbal and written. Excellent numerical skills including some knowledge of statistics Understanding of data protection principles Comfortable working with staff at all levels. Ability to self-organise, prioritise and track tasks. PREFERRED QUALIFICATIONS Experience in using Python or R for analysis and incorporating into Power BI visualisations. Familiarity with advanced charting technologies such as Deneb, SVG or D3.js ideal. Familiarity with assessment data and psychometric principles Experience with Azure is a plus. Experience with Agile development practices (Scrum or Kanban) is a plus. What We Offer: Exciting Projects: We focus on industries like High-Tech, communication, media, healthcare, retail and telecom. Our customer list is full of fantastic global brands and leaders who love what we build for them. Collaborative Environment: You Can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities! Work-Life Balance: GlobalLogic prioritizes work-life balance, which is why we offer flexible work schedules, opportunities to work from home, and paid time off and holidays. Professional Development: Our dedicated Learning & Development team regularly organizes Communication skills training(GL Vantage, Toast Master),Stress Management program, professional certifications, and technical and soft skill trainings. Excellent Benefits: We provide our employees with competitive salaries, family medical insurance, Group Term Life Insurance, Group Personal Accident Insurance , NPS(National Pension Scheme ), Periodic health awareness program, extended maternity leave, annual performance bonuses, and referral bonuses. Fun Perks: We want you to love where you work, which is why we host sports events, cultural activities, offer food on subsidies rates, Corporate parties. Our vibrant offices also include dedicated GL Zones, rooftop decks and GL Club where you can drink coffee or tea with your colleagues over a game of table and offer discounts for popular stores and restaurants!

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3.0 - 6.0 years

3 - 6 Lacs

ahmedabad

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Job Title:Sr. International Regulatory Affairs Executive/Officer Companies: Pharma Location: Ahmedabad Bodakdev Exp: 4-6 Yrs email: jobs@winstonhrservices.com Whatsapp: 7383005000 Openings: 02 Required Candidate profile Preparing & review Dossiers for registration of products in various ROW markets Legalization of FDCA documents for respective country registration Preparing, managing FSC & COPP applications for FDCA

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14.0 - 24.0 years

0 - 0 Lacs

pune, nashik, kalyan

On-site

Role : Deputy General Manager - Sales (ROW Market) Geographies Covered : East Africa : Uganda, Ethiopia, Kenya, Tanzania, Malawi, Zambia, Zimbabwe, Nigeria, Ghana French West Africa: Ivory Coast, Benin, Senegal, Mali, Burkina Faso, Togo Company name : Medley Pharmaceutical Limited Company Profile : We are progressive WHO-GMP, MHRA UK and USFDA certified company beside approval by several other countries and one of the fastest growing amongst the top 40 pharmaceutical companies in the country as per IMS. We are currently present in about 30 countries including UK, European countries & ROW. * Working Days & Time : Monday to Saturday. 2nd & 4th Saturday Off * Flexi Time : (9.00 am 10.00 am) with 8.45 Hours login * Location : Andheri East, Mumbai * Reporting : Sr GM Sales & Marketing Job description : To lead and drive sales growth in the Rest of the World (ROW) markets, particularly focusing on the African continent (East Africa and French West Africa), by expanding business operations, developing strong distributor networks, launching new products, and ensuring compliance with regulatory requirements. Key Responsibilities: Drive P&L for ROW region, ensuring achievement of sales targets and profitability. Build and manage strong relationships with distributors, agents, and local partners across assigned geographies. Identify new business opportunities and facilitate market entries in untapped or emerging regions. Lead product registrations, market approvals, and ensure compliance with local regulatory frameworks. Collaborate with cross-functional teams (Regulatory, Supply Chain, QA/QC, and Marketing) to ensure timely execution of plans. Monitor market trends, competitor activities, and regulatory updates to adjust sales strategy. Plan and execute product launches with a clear go-to-market strategy. Negotiate pricing, contracts, and annual business plans with distributors and partners. Conduct periodic market visits to strengthen business relationships and review performance. Train and guide the local sales teams/distributors to drive product knowledge and sales capabilities. Desired Profile Expertise: Proven track record of managing ROW markets and delivering consistent sales growth. Strong understanding of regulatory processes and market dynamics in African countries. Excellent negotiation, leadership, and communication skills. Willingness to travel extensively across African countries, if it is required. Education: Graduation in Science + MBA Experience: 15+ years of experience in International Pharma Sales with at least 5 years in African markets Interested candidate, please email your cv to: prarthanaw@datrax.in or reply on job posting.

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3.0 - 6.0 years

0 - 0 Lacs

ahmedabad

Work from Office

Role & responsibilities To explore in-licensing partners for RoW markets (Asia , Middle East , Africa) Project Management for RoW markets New Product identification and Portfolio management. Good knowledge of Regulatory guidelines for above markets. Commercial evaluation of the business case to make it viable to execute new business/ existing business Manage timely delivery of projects by keeping track of all internal activities. Take responsibilities for business development activities in the designated markets. Launch executions, critical order management for designated business Manage customer relationship, retain and grow existing business Sound analytical & logical skill, ability to learn & develop skill Good communication & presentation skills• Preferred candidate profile Graduate in Science / Pharmacy / Engineering (related to Bio) and post-graduation in Science or Management or Pharmacy Experience: Minimum 3 4 Years of relevant experience Attributes: Ability to multitask, Capabilities in strategically & analytical thinking, operational planning, creative execution with excellent communication skills (written and oral) will be key requirements

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2.0 - 7.0 years

3 - 8 Lacs

hyderabad

Work from Office

Regulatory Affairs Job Opportunity! Desired Experience : 3- 9 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited) Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc. Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc. Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO. Application for Post Approval Change(s), Variations and Comparability packages Author, review and submission of responses to India, EM, WHO and Regulated markets.. Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc.. Handling the Health Agency audits for India, EM, Regulated and WHO inspections Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External). Review of Artworks (Labels and Package Insert) and Pack Profiles. Any other regulatory support required by the organization per submission need. Interested Candidates having relevant experience can send in their CVs to HR.Intern4@biologicale.com by mention the subject as Applying for "Regulatory Affairs"

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3.0 - 8.0 years

0 - 1 Lacs

Bengaluru

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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.

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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

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8.0 - 10.0 years

8 - 10 Lacs

Tumkur, Chikkaballapura, Ramanagara

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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

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5.0 - 10.0 years

3 - 6 Lacs

Andhra Pradesh

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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.

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5.0 - 8.0 years

12 - 17 Lacs

Thane, Navi Mumbai, Mumbai (All Areas)

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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

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5.0 - 10.0 years

6 - 10 Lacs

Kolkata

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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

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4.0 - 8.0 years

5 - 9 Lacs

Dholka

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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

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11.0 - 17.0 years

9 - 13 Lacs

Ahmedabad

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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

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