61 Row Jobs - Page 2

Regulatory Functional: Compilation of dossier for ROW market as per the country specific requirements (from Module-1 to Module 5) Ensure compliance to county specific regulatory requirements (i.e., Africa, ASEAN, CIA, Gulf, Asia pacific, Latin America) ¢ Ensure labeling compilation as per the country specific requirements ¢ Review of DMFs of complex peptide drug substances ¢ Post approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or client ¢ Experienced with handling drug device combination regulations and understand the requirements for submission in line country specific requirement (Prefilled syringes and disposable pens) ¢ To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations ¢ Ensure timely response to the deficiencies received from the agencies ¢ To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions ¢ Life cycle management of products to include renewals, reviewing & approving the change controls and ensures product continuity through filing and timely approvals of variations. Support the continuing activities through coordination with various stakeholder ¢ Approval package compilation and provides support for lunching of the approved product

Ensure that submission of CTD, eCTD, aCTD dossiers. Meet all regulatory requirements. Participate in contacting competent authorities for respective products. Preparation of regulatory submissions (Dossier, Variations) to authorities. Required Candidate profile Should have deep knowledge of Preparation and submission CTD, eCTD and ACTD Dossiers to ROW drug regulatory authorities. Should be able to handle queries, Artworks check, regulatory planning.

We, Unison Pharma - One of the fastest growing global pharma company are seeking candidates with rich experience to join our International Business (Asia/ Africa markets) role. Position: Executive / Sr. Executive / Assistant Manager Job Location: Head Office, Ahmedabad (2nd & 4th Sat Off) Frequency of Travel - Need based Key Accountabilities/ Responsibilities 1. BD, Marketing & Sales Identifying and Finalizing potential partners followed by CDA & the main agreement Finalize products for registrations Prepare business plan including target prices and yearly sales quantities Prepare annual sales & expense budget, territory wise & thus establish the profit / loss scenario. Managing sales by developing a business plan that covers sales, revenue, and expense controls. Overseeing the activities and performance of the agency & / or sales team. Promoting the organization and products; Expanding foot-print of the company in the territory Impart training & / Or knowledge of the products to the targeted audience. 2. Backend activities Ensure timely preparation of product dossiers by RA, followed by in-time submission in the territory by partner Timely update of products lying under registrations from the partners Collecting purchase orders from the partners once the products are registered Punching of purchase orders into the system Timely receipt of payments Ensure timely dispatch of the products Interested candidates to apply here or email their updated profile on maitrivakil@unisonpharmaceuticals.com

JOB TITLE: POWER BI ADMIN / DEVELOPER LOCATION: Mumbai/Pune EXPERIENCE: 4+ years ROLES RESPONSIBILITIES Power BI Administrator SQL Server Administrator Candidate should be able to demonstrate all Power BI Admin activity Candidate should be able to demonstrate SQL Server Admin Row Level Security (RLS) Security Configuration Workspace Configuration Power BI Premium Capacity DAX Power Query SQL Paginated Reports

1.Daily Liaison with Partner on Execution 2.Tracking partner productivity & teams on ground 3.Reporting of Daily Progress to PM and Central Team 4.Inspect the Poles deployed by Partner 5.Getting the Cluster Accepted by Airtel post 85% Deployment 6.Coordinate on final AT document

Job Description: Surveyor-Land - ROW Job Purpose: The Surveyor-Land plays a critical role in supporting the project team with land acquisition, regulatory approvals, and stakeholder management for renewable energy projects. The role involves ensuring legal compliance, negotiating land deals, and collaborating with authorities to facilitate seamless project execution. Key Accountabilities: - Experience in RE projects in surveying for Land procurement: This includes in-depth tasks such as coordinating with local authorities, ensuring land title clarity, handling legal due diligence, and mitigating land-related risks for smooth project execution. - experience in AutoCAD: Good hands on experience in AutoCAD for the digitizing of revenue map in to dwg format with ground reference. - Global Mapper: Knowledge of converting dwg file in to KML file. - Google earth: Good knowledge of using the kml file of the project on the ground implementation. - Survey equipment's Total station: Hands on experience using the Total Station (Trimble, Sokia, Leica etc.) for contour survey, toposurvey, etc. - DGPS and associated tools: Hand on experience of using the DGPS equipment for surveying (Equipment make Trimble, Leice, etc.) Required Skills & Experience: Good knowledge about the Solar and Wind project land requirements and accordingly to survey the land, demarcation, premise etc. Preparing the FMB sketch for the wind location with pathway Preparing the project map for the solar project

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. 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 9619744167. Perks and benefits

Job Description: Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per EAEU guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Green Earth Exim India Pvt. Ltd 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

Role Description This is a full-time on-site role for a Senior Engineer/Manager in Land Acquisition and Project Development at ILIOS Power in Hyderabad. The role will involve tasks such as land use planning, market research, acquisitions, financial analysis, and project development. Responsibility Acquiring land for the company in the states of Madhya Pradesh and Andhra Pradesh to install solar power pants. Obtaining all necessary approvals Working with land aggregators, legal consultants and other relevant stakeholders for conducting due diligence on earmarked land Resolving all Right of Way (ROW) issues related to land evacuation infrastructure Qualifications Professional qualification- Graduate 4-7 years of experience in land acquisition Analytical Skills and Finance knowledge Strong project management abilities Excellent communication and negotiation skills Ability to work collaboratively in cross-functional teams

Job Title: Senior Executive Drug Regulatory Affairs (DRA) Job Responsibilities: Prepare and review regulatory dossiers in compliance with country-specific guidelines, including CTD, ACTD, and other regional formats. Manage dossier submissions for new registrations, re-registrations, and product variation filings. Review quality and administrative documents to ensure completeness and accuracy before submission. Conduct literature searches to compile non-clinical and clinical data for dossier preparation. Develop and review SmPCs, Package Inserts, and labeling information in accordance with regulatory requirements and initial dossier submissions. Evaluate and approve artwork for export products. Collaborate with cross-functional departments including QA, QC, Production, ADL, and R&D to streamline regulatory processes. Address and resolve queries from regulatory authorities such as the FDA and other relevant agencies. Maintain communication with international clients regarding dossiers, sample requirements, and regulatory updates. Draft and review applications for product permissions, COPPs, and FSCs. Market Exposure: ASEAN: Philippines, Vietnam, Myanmar, Laos, Cambodia, Thailand Africa: Uganda, Nigeria, Ethiopia, Mozambique, Tanzania, Cameroon, Ivory Coast, Benin, Burundi, Togo, Congo, ZaZiBoNa, South Africa LATAM: Peru, Ecuador, Bolivia, Guatemala, Nicaragua, Costa Rica CIS: Kyrgyzstan, Uzbekistan, Russia, Ukraine Other Regions: Georgia, Sri Lanka, Azerbaijan

We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets. Roles & Responsibilities: Dossier Preparation and Review: Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing. Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements. Agency Communication and Submission: Develop and submit quality responses to agency queries within specified timelines. Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents. Documentation and Compliance: Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements. Prepare, update, and review product labeling and information. Cross-functional Collaboration: Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation. Manage notifications and documentation for implementation of amendments. Regulatory Process Management: Ensure documentation practices align with organizational and regulatory standards. Maintain organized and accurate records for all regulatory activities.Role & responsibilities Requirements: Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm). Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets. Proficiency in electronic publishing tools and CTD/eCTD dossier formats. In-depth understanding of South Africa-specific regulatory guidelines. Strong organizational, communication, and documentation skills. Ability to prioritize multiple projects and meet strict deadlines. Collaborative team player with a proactive and detail-oriented mindset.

*Responsible for sourcing of API, KSM & all critical products for R&D projects & commercials in Regulated & Un-regulated Market. *To support projects and to realize year-on-year productivity improvements, cost savings, and process improvements *Planning, organizing, and managing projects taking into account priorities.

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 regulations). Maintain accurate and up-to-date records of regulatory documents, approvals, and communications. Monitor and ensure compliance with post-marketing regulatory requirements, such as periodic updates, renewals, and reporting obligations. 3. Labeling and Packaging Compliance: Review and approve labeling and packaging materials to ensure they meet the regulatory requirements of each country in the assigned regions. Coordinate changes in labeling as per the updated guidelines and regulations from local health authorities. 4. Product Development Support: Work closely with product development teams to ensure regulatory requirements are considered during product formulation and development. Provide regulatory advice on technical issues related to injectables, including formulation, packaging, and stability studies. 5. Regulatory Intelligence: Stay updated on changes in regulations, guidelines, and standards in the ROW, Africa, LATAM, CIS, and ASEAN regions. Communicate any changes or updates in regulatory requirements to relevant departments and ensure compliance with new regulations. 6. Communication and Coordination: Act as a point of contact between the company and regulatory bodies in the assigned markets. Coordinate with external partners, consultants, and distributors to facilitate regulatory submissions and product launches. 7. Cross-functional Collaboration: Collaborate with Quality Assurance, Manufacturing, and R&D teams to ensure that regulatory requirements are met at every stage of product development and manufacturing. Support in audits and inspections conducted by regulatory agencies and provide necessary documentation and information. 8. Product Registration Lifecycle Management: Manage the entire lifecycle of product registrations, including initial submissions, renewals, variations, and amendments. Ensure timely submission of regulatory documents to maintain product approvals and licenses. 9. Risk Management and Problem-Solving: Identify potential regulatory risks and devise strategies to mitigate them, ensuring uninterrupted market access for products. Provide solutions and regulatory strategies to resolve any issues or challenges related to regulatory submissions. Preferred candidate profile Must have experience in Injectables dosage forms. Perks and benefits

RA Ensure compliance with regulations,prepare & submit regulatory filings, & maintain existing registrations,ensuring API & related products meet legal requirements.Must Knowledge of Dossier Making,Product Permission,Application Permission,ROW Market

We are looking for candidates for Executive / Sr. Executive / Manager / Sr. Manager - International BD handling ROW / LATAM / Asia / CIS and will be based at Juinagar, Navi Mumbai. Job Description as below - Role & responsibilities : Responsible for Business Development of pharma formulations for International Business . Identify New Sales opportunities and Increase New Business in Regulated or Semi Regulated markets. To understand and monitor the registration guidelines & Process, and to obtain the registration of the products To identify and finalize the agreements with appropriate business partners in various countries. Monitoring export marketing, regulatory affairs, costing, negotiation, executions, logistics and export documentations. Interaction with manufacturer for product sourcing Maintain up to date data on competitive products Managing distributors / Vendors in International market To ensure proper coordination with CFT Interested candidates can mail / WhatsApp your resume or if you have good references you can share - Thanks & Regards, Vaibhavi Behere HR Department Titan Laboratories Pvt Ltd vaibhavi.b@titanpharma.com

Candidate job profile Qualification degree B. Pharm or M. Pharmacy and minimum 3 years experience in dossier preparation (Cis & Latam Market). Job Description Dossier Preparation & Compilation

Sterlite Power and Transmission is hiring for Chief Manager - Projects Location - Andhra and Karnataka. Exp - 16 years to 18 years Education- B.Tech / B.E. Language Known - Hindi Mandatory- Must have handled 60Kms-300Kms Power Transmission lines as a Project Manager. Role Summary- End to end Construction, monitor Project Execution from 400Kv to 765Kv, Row issues, Administration Coordination. Overall monitoring of Execution of Project, Coordination with EPC and driving them to deliver the desired progress. Checking of JMC as per site execution and certification over PMS. Basic idea about civil work and stringing work in transmission Lines. Monitoring of RoW issues & Close coordination with Local Administration for obtaining the required support and clearances. Capable to attend high level meetings at DC/ADC/State Secretariat office. Preparation of reports/row related data in excel/ppt forms. Evaluation of various utilities data w.r.t ROW and make a conclusive report to understand the different scenarios. Following up with the related government/non-government bodies for obtaining the required Statutory clearances for Transmission lines. Checking and understanding of required engineering drawings for the Project execution. Driving and maintaining the Organizational QHSE norms & targets.

Hiring for Jr. Executive / Sr. Executive for RA - API with 2 to 5 Years of experience.

D ossiers Planning, Allocation, Execution and Monitoring for timely submission to health agency for obtaining product and company registration in LATAM, APAC and CIS markets. • Managing the work delegation to the Regulatory Team & careful monitoring of the monthly submissions, filling of variation & registrations • Review of Dossiers in CTD, ACTD & Country specific format • Responsible for Query response & filling of product variation to the different health authorities • Review of SPC, Labeling & PIL • Review of validation protocol for proposed commercial batch sizes • Obtaining Product / Company registration through monitoring the regulatory requirements, maintaining online database & product lifecycle management • CRM, Scientific & Corporate Communications along with management of internal / external customers and various health agencies • Experienced Site/product Audit of Ukraine, Kazakhstan, Uganda, Malaysia, Philippines. neetij@selectsourceintl.com

Roles and Responsibilities Ensure compliance with regulatory requirements for API manufacturing, bulk drugs, and ECTD submissions. Prepare dossiers for US FDA, EU GMP, and other international markets. Coordinate with cross-functional teams for timely submission of applications. Maintain accurate records of regulatory documents and updates. Provide guidance on drug regulatory affairs to internal stakeholders.

Fortpoint Hero is looking for Assistance 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 ,

Fortpoint Hero is looking for Assistance 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 ,

BDM is responsible for identifying & developing new business opportunities in overseas markets, managing relationships with international clients, negotiating deals & driving sales growth requiring a deep understanding of the pharmaceutical market.

Hands on Experience on Regulatory Affairs of various ROW markets. Lead the team for day to day RA activity. Required Candidate profile Experience of working on Liposomes/Pegylated Liposomes/Microspheres/Resomer baseddepot/Dual chamber based components / Particle size based delayed drug delivery injectables/Lyophilised dosage forms.a