47 Ema Jobs

As a Safety Specialist I at Precision, your role will involve performing all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR) for clinical trials and/or post-marketing safety programs. Key Responsibilities: - Process ICSRs following Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability - Enter data into Argus Safety Database - Code events, medical history, concomitant medications, and tests - Draft case narratives - Assess information to be queried and follow up until queries are satisfactorily resolved - Generate timely, consistent, a...

Role & responsibilities Minimum of 10 years of Life Science industry experience, with substantial exposure to regulatory affairs. Hands on experience and demonstrated expertise in Chemistry, Manufacturing, and labeling processing Comprehensive understanding of global regulatory framework, including FDA, EMA, ICH and other international standards. Excellent communication skills both written and verbal Meticulous attention to detail and organizational prowess Proficiency in project management and cross-functional collaboration Strong analytical and problem-solving skills Ability to navigate and interpret complex regulatory landscapes across multiple regions Good understanding of Quality Manage...

Key Responsibilities: Business Development & Client Management Identify, acquire, and manage global clients in the API CDMO space across US, EU, Japan, and RoW markets. Build strategic partnerships with innovator pharma, biotech, and specialty pharma companies. Lead high-level client interactions, proposal development, pricing strategy, and contract negotiations. Maintain long-term client relationships and ensure repeat business through high-quality service delivery. Project & Portfolio Leadership Oversee the entire lifecycle of client projects, from R&D and process development to scale-up and commercial manufacturing. Ensure timely, cost-effective, and compliant delivery of client projects....

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 pub...

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 pub...

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficienc...

Exp. in Biopharmaceuticals Biosimilars consulting and strategy oriented projects Strong foundation in pharmaceutical and drug dev. lifecycle understanding of commercialization process, or Biopharmaceuticals o Excellent communication skills

position: Contract to Hire(C2H) Skill: IT Configuration Engineer Experience:6+ Location: Pan India Notice Period: Immediate to 15 Days Job Descrption: Description During the implementation of the new MES environments, the IT configuration engineer is the local resource assisting in setting up the interfaces to MES, performing the system configurations and writing & reviewing validation documentation and executing test cases. Profile: - MES knowledge (PAS-X certification) MES project experience & setting up IT infrastructure & system configuration for this - Familiar with life sciences manufacturing processes & standards (inc. GMP practices) Candidates who are Interested for above Position , ...

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed...

Required Skills and Qualifications: Collect and maintain hashtag#structureddata from global hashtag#regulatoryauthorities (e.g., hashtag#EMA , hashtag#FDA , hashtag#TGA ), hashtag#HTA agencies (e.g., hashtag#NICE , hashtag#HAS , hashtag#CADTH ) and pricing bodies (e.g., hashtag#DMD , hashtag#CODAGE , hashtag#PBS ) • Masters degree in hashtag#pharmacy . • Strong interest or foundational knowledge in hashtag#pharmaceuticaldrug development, hashtag#regulatory affairs, or hashtag#clinical trials. • Excellent attention to detail and ability to work with hashtag#structured data sets . • Proficiency in using hashtag#MS Excel , hashtag#Word , and hashtag#basic data tools.

Required Skills and Qualifications: Collect and maintain hashtag#structureddata from global hashtag#regulatoryauthorities (e.g., hashtag#EMA , hashtag#FDA , hashtag#TGA ), hashtag#HTA agencies (e.g., hashtag#NICE , hashtag#HAS , hashtag#CADTH ) and pricing bodies (e.g., hashtag#DMD , hashtag#CODAGE , hashtag#PBS ) • Masters degree in hashtag#pharmacy . • Strong interest or foundational knowledge in hashtag#pharmaceuticaldrug development, hashtag#regulatory affairs, or hashtag#clinical trials. • Excellent attention to detail and ability to work with hashtag#structured data sets . • Proficiency in using hashtag#MS Excel , hashtag#Word , and hashtag#basic data tools.

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

You are invited to join a German Based MNC in Bangalore as a Validation Engineer with a focus on Installation and Qualification of Pharma Machinery. This exciting opportunity requires 3-6 years of experience, offering a competitive CTC of 6-8 LPA. The location for this role is Hebbal, Bangalore, and candidates must be open to both domestic and international travel. Your responsibilities will include ensuring that qualification projects meet customer requirements, clarifying customer qualification needs during kick-off meetings, and documenting agreements in the Qualification Master Plan (QMP). Additionally, you will moderate and document risk analyses, create various test documents, conduct ...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

Job Description Manager / Sr. Manager (Contract Manufacturing & Quality Compliance) Location: Pune Department: Manufacturing & Quality Reports To: Head – Operations / Quality Role Overview We are seeking an experienced and proactive professional to manage and coordinate production activities at contract manufacturing sites. The ideal candidate will have strong expertise in production planning, quality systems, regulatory compliance, and cross-functional collaboration to ensure timely supply of high-quality products in alignment with business objectives and global regulatory expectations. Key Responsibilities Production & Planning Manage and oversee production planning at contract manufacturi...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

Detailed Job Role: Monitor and document drug safety data, perform adverse event reporting, assist with pharmacovigilance and risk management. KRA (Key Responsibility Areas): Case assessment, adverse event documentation, timely reporting, risk communication KPI (Key Performance Indicators): Event processing time, report accuracy, submission regularity, follow-up efficiency Job description: Job Summary:We are seeking a meticulous Drug Safety Associate to monitor, document, and manage drug safety data while supporting pharmacovigilance and risk management activities. The ideal candidate will ensure timely and accurate reporting of adverse events, contributing to patient safety and regulatory co...

As a Process Equipment Systems Engineer in the pharmaceutical manufacturing industry, your primary responsibility will be to design and specify process equipment systems for manufacturing plants. This involves ensuring that the equipment aligns with project goals and meets regulatory standards such as GMP, FDA, and EMA. You will need to select appropriate equipment based on factors like material compatibility, process requirements, automation, and cost-effectiveness. Your role will also involve developing equipment specifications, datasheets, and technical documentation for procurement and installation purposes. It is essential to have hands-on experience in installing isolator-based filling...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations including Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. Our manufacturing facility, situated in Vapi (Gujarat), holds approval from global regulatory authorities. Founded in 1983, UMEDICA operates in over 85 countries across the globe, encompassing EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. Upholding a culture of innovation & continuous improvement, we at UMEDICA constantly strive for excellence. We are currently looking for a dynamic and experienced Manager/ Sr. Manager specializing in ...

For the past 20 years, ProPharma has been dedicated to enhancing the health and well-being of patients through the provision of expert advice and guidance that enables biotech, medical device, and pharmaceutical organizations of all sizes to confidently progress scientific innovations and introduce new therapies. ProPharma collaborates with its clients utilizing an advise-build-operate model throughout the entire product lifecycle. With profound expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers a comprehensive suite of customizable consulting solutions that mitigate risks and exped...

Role : - Assistant Manager -Vendor Management QM. Location : Baddi Company : Fresenius Kabi Oncology Ltd. Key Responsibilities : To establish, execute and monitor compliance with the procedure for the selection, qualification, development, maintenance, and discontinuation of External Providers (Suppliers of materials & services). Collection of Supplier audit needs from FKOL sites and co-ordination with FK Global Sourcing teams to finalize Global Audit Planners. Track and Execute supplier audits assigned to FK-India as per the global planner and maintain up to date status in the global External Audit Management database, with regular updates to FK Global Sourcing team. Management QA activitie...

Responsibilities: * Collaborate with cross-functional teams on study setup, data cleaning, and reporting. * Manage clinical data from CRFs using RAVE software following ICH-GCP guidelines. Health insurance Annual bonus Provident fund Accidental insurance Life insurance Mobile bill reimbursements

The Production Planner is responsible for developing and managing efficient production schedules to meet demand forecasts, optimize resource utilization, ensure compliance with GMP and regulatory standards, and minimize downtime in a pharmaceutical manufacturing environment. Key Responsibilities: - Develop and maintain detailed production plans based on sales forecasts, inventory levels, and customer orders. - Coordinate with procurement, quality assurance, warehouse, and manufacturing teams to align production plans. - Monitor production progress and adjust schedules as necessary to avoid delays and ensure timely product delivery. - Ensure planning aligns with cGMP, regulatory requirements ...

The Group Leader -GCP QA (Clinical) at Syngene in Bangalore is responsible for managing the GCP QA auditors team and conducting various audits related to clinical research, process audits, Investigational Site audits, and safety database audits. The role involves assessing systems and practices to improve the GCP Quality System practices in alignment with the national and international GCP Quality System standards. The Group Leader must ensure compliance with quality (GxP) regulations and standards, making the facility audit-ready at all times. Key Responsibilities include: - Scheduling and conducting GCP QA audits to ensure compliance with regulatory requirements - Developing risk-based aud...

Work Your Magic with us! Ready to explore, break barriers, and discover more We know youve got big plans so do we! Our colleagues across the globe love innovating with science and technology to enrich peoples lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That&aposs why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas su...