15 Ema Jobs

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Job Location: Ahmedabad Experience Year : 3+ Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define validation strategy based on risk and regulatory impact. Documentation: Create and review validation documentation including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. Document test results and deviations. Software Testing as per requirements Internal/ external release. Compliance: Ensure systems comply with applicable regulations (FDA, EMA, GAMP 5). Participate in audits and inspections. Maintain audit trail and data integrity practices. Risk Assessment: Perform risk assessments and impact analyses for changes to validated systems. Change Management: Evaluate system changes and determine need for revalidation. Support Change Control processes. Collaboration: Work with QA, IT, engineering, and business units to support the validation lifecycle. Train users and system owners on compliance requirements. System Lifecycle Support: Manage validation activities through system development, implementation, maintenance, and decommissioning.

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to RD staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

We are looking for an experienced Senior Implementation Specialist with deep expertise in the life sciences industry to lead and execute complex implementations of our technology solutions. This role requires a seasoned professional with over 10 years of implementation experience, strong technical knowledge, and a proven track record in the life sciences domain. The ideal candidate will ensure seamless deployment, integration, and optimization of Freya Fusion, managing both client expectations and regulatory requirements. Key Responsibilities: Project Leadership : Lead the end-to-end implementation of Freya Fusion, overseeing all phases from project scoping and requirements gathering to configuration, testing, and go-live. Client Relationship Management : Act as the primary point of contact for clients, offering expert guidance, managing expectations, and consistently maintain positive relationships to ensure successful adoption of Freya Fusion. Solution Configuration : Collaborate closely with technical teams to configure Freya Fusion according to client specifications, ensuring integration with existing enterprise systems and compliance with industry standards. Data Migration & Compliance : Manage and execute data migration strategies, conducting thorough data validation to ensure accuracy and compliance. Detailed Project Planning : Develop and maintain comprehensive project plans, including timelines, resource allocations, and milestones, while actively identifying and mitigating risks. Regulatory Compliance : Ensure all implementations meet global regulatory standards relevant to the life sciences industry (FDA, EMA, GxP, etc.), maintaining clear documentation for compliance and audit purposes. Client Training & Post-Implementation Support : Conduct training sessions, develop user guides, and provide continued support to clients to facilitate seamless onboarding and system adoption. Process Improvement : Collaborate with internal teams to continuously improve implementation processes, sharing insights to enhance client satisfaction and optimize solution delivery. Required Qualifications: Educational Background : Bachelors degree in Life Sciences, Computer Science, Information Systems, or a related field. Advanced degrees or certifications in Project Management (PMP) or Life Sciences regulatory standards are preferred. Extensive Experience : 10+ years of experience in software implementation (SAAS -Preferred), with at least 5 years focused in the life sciences industry (pharmaceuticals, biotech, MedTech, etc.). Technical Expertise : Strong background in implementing SaaS platforms in regulated environments; experience with Regulatory systems/tools in Life Sciences or similar RIMS or regulatory platforms is highly desirable. Project Management Skills : Demonstrated expertise in project management and handling complex, high-stakes projects, using tools like JIRA, Asana, or MS Project. Regulatory Knowledge : In-depth understanding of life sciences regulations and standards, including FDA, EMA, and GxP requirements. Exceptional Communication and Negotiation Skills : Outstanding client-facing skills with the ability to convey complex technical information to a diverse audience. Problem-Solving & Adaptability : Skilled at troubleshooting and resolving client-specific challenges with a flexible, solutions-oriented approach. Preferred Qualifications: Previous experience with SAAS platforms in Life Sciences or equivalent regulatory and compliance platforms. Proven track record in leading system integrations, data migrations, or configuration management in SaaS environments. Experience working within an Agile framework and Linear Framework

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (both Open and Closed Parts) for submission to national and international regulatory authorities. Ensure data integrity and compliance with ICH and other global regulatory guidelines . Regulatory Documentation & Submissions: Prepare, review, and submit CDSCO-specific checklists for New Drug Applications (ND) and SND (Subsequent New Drug) filings for APIs. Regulatory Compliance: Stay current with evolving regulations and guidelines issued by CDSCO, ICH, USFDA, EMA , and other global regulatory bodies. Assist in audits and regulatory inspections by preparing and presenting required documentation. Liaison with Regulatory Authorities: Coordinate with Local FDA & CDSCO Liaison concerned person and other regulatory authorities for smooth regulatory processes and communication. If interested please share updated resume on corporate.hr@exemedpharma.com

Job Description Business Development Job Title: Manager / Sr. Manager/ AGM- Business Development Experience: 7– 15 Years Function: To handle Overall Business Development (Emerging & Semi Regulated Market) Job Responsibilities 1. Market Research and Strategy Development: Conduct research to identify new business opportunities and trends in regulated and emerging markets. Develop and implement strategic plans for market entry and expansion in existing or new market. Analyze competitor activities, market trends, and regulatory landscapes to adapt business strategies. 2. Business Development: Identify and build relationships with potential business partners, distributors, and clients in assigned markets. Negotiate and finalize agreements, ensuring mutual benefits and compliance with company policies. Maintain strong relationships with existing partners to ensure continued growth and collaboration. 3. Regulatory Compliance: Ensure business activities align with pharmaceutical regulations (FDA, EMA, local market rules). Collaborate with regulatory teams to navigate market entry requirements. 4. Client Relationship Management : Build and maintain strong relationships with key clients, partners, and stakeholders in international markets. Collaborate with clients to understand their needs and provide tailored solutions. 5. Team Leadership and Management : Supervise and manage a team of Business Development Managers, ensuring alignment with organizational goals. Provide mentorship, training, and support to team members to enhance their performance and skill sets. 6. Business Performance Tracking and Communication: Monitor sales performance, market share, and ROI in the assigned markets. Prepare periodic reports to provide insights and recommendations to senior management. Facilitate effective communication between the team and other departments. 7. Operational Oversight : Ensure smooth execution of business development activities and adherence to timelines. Oversee contract negotiations, proposal submissions, and closing deals. Interested candidates are can apply on Darpana: 9978604075 or can email me on darpana@upman.in

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

Job Title: Regulatory Publishing Specialist SUMMARY Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs and JNDAs and their amendments and supplements in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, JP, ICH, etc). JOB RESPONSIBILITIES: • Electronically format and publish submission components in line with regional specifications. • Compile and validate electronic submissions in publishing software (Lorenz Docubridge) • Accountable for dispatching finalized submissions through the appropriate regulatory authority portal and archiving in Veeva. • Responsible for overseeing routine submissions, including the creation of submissions in Veeva. • Provides guidance on good documentation and submission practices. • Assist with developing and maintaining Regulatory document processing and Regulatory submission. publishing standards and procedures. • Identifies and communicates regulatory system enhancement needs or technical issues. • Assists with regulatory inspection activities. • Collaborates with vendors who support Regulatory submission document related tasks. • Provides support and backup to management as needed. JOB REQUIREMENTS: Education • Bachelors Degree Experience • Minimum of 2 years experience with Regulatory Operations • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). • Strong knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. • Familiarity with Veeva Vault & Lorenz Docubridge would be advantageous. Requirements • Full-time, office-based position (5 days per week) • Working standard regional hours

Role & responsibilities - Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries. - Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance. - Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support. - Coordination with internal and external stakeholders for regulatory filing related documentation. - Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency. - Hands on experience of post approval variations and Annual reports. Preferred candidate profile Master of Pharmacy Perks and benefits As per Company Standards

*Process Management: Expertise in overseeing production processes, ensuring efficiency, compliance, and quality standards. *Production Planning & Scheduling: Ability to develop production plans that align with customer demand and business goals, optimizing resource utilization. *Leadership & Team Management: Proven track record in leading cross-functional teams, fostering collaboration, and driving high-performance cultures. *Regulatory Knowledge: Deep understanding of industry standards (GMP, FDA, EMA, ICH) and the ability to ensure compliance across all levels of production. *Quality Assurance: Strong focus on maintaining product quality, managing deviations, and implementing corrective and preventive actions (CAPA). Problem-Solving & Troubleshooting: Skilled at identifying issues in the manufacturing process, analyzing root causes, and implementing solutions quickly. *Process Optimization: Familiarity with Lean Manufacturing, Six Sigma, and other methodologies to improve operational efficiency and reduce costs. Equipment Maintenance & Management: Proficient in overseeing the upkeep, calibration, and validation of manufacturing equipment. *Safety & Compliance: In-depth knowledge of occupational health and safety standards, ensuring safe working environments.

My profile - linkedin.com/in/yashsharma1608 Pine Script Developer (TradingView Specialist) Experience: Minimum 2 Years WORK FROM OFFICE - nOIDA IMMEDIATE joiners working days - 5/6 - depending on interview About the Role We are seeking a highly skilled Pine Script Developer with strong TradingView expertise to join our AI-powered trading platform team. Youll be responsible for building, optimizing, and maintaining advanced custom indicators, signal overlays, and script-based strategy tools. Key Responsibilities Develop, optimize, and debug Pine Script indicators and strategies on TradingView Translate AI signals and logic into visual TradingView-compatible overlays Create invite-only and public scripts with clean, efficient visualization Collaborate with data science, UI/UX, and backend teams for integrated deployment Maintain code quality, signal accuracy, and update responsiveness Required Skills 2+ years of hands-on Pine Script experience Deep understanding of TradingView charts, tools, and publishing processes Strong grasp of technical indicators (RSI, MACD, EMA, FVG, Volume, etc.) Experience creating overlays, signals, alert logic, and multi-timeframe setups Ability to translate written trading logic into accurate Pine Script code Preferred (Bonus) Prior work on invite-only or monetized indicators Familiarity with AI signal translation or webhook integration Experience integrating TradingView alerts with external bots or platforms

The ideal candidate will have experience in graphic design with a focus on regulated environments and a strong understanding of pharma-specific packaging components such as labels, cartons, leaflets, and blister packs.

Hi We are hiring for Regulatory Submissions Publisher . Job Purpose: Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) QC submission dossiers or parts of submission dossier output of low-to-moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre-established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 369 b) For Position in Bangalore Search : Job Code # 370 c) For Position in Hyderabad Search : Job Code # 371

Manage the technology transfer process for established products, ensuring robust and compliant manufacturing processes e.g. implementation of new API sources. Write, review, and maintain regulatory response documents, justification reports, and risk assessments related to technology transfer activities. Oversee the preparation and review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for smooth transfer and manufacturing. Review process validation protocols and reports. Coordinate with R&D, production, quality assurance, and regulatory teams to ensure alignment on project deliverables and timelines. Troubleshoot and optimize manufacturing processes addressing deviations and improving efficiency. Conduct technical risk assessments to identify and mitigate potential issues during and post-transfer. Maintain comprehensive documentation to ensure compliance with regulatory standards (e.g., FDA, EMA, cGMP) and internal quality guidelines. Stay updated on regulatory trends and industry standards to continuously improve documentation practices and technology transfer methodologies.