Average salary: Rs3,249,999 /yearly
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- ...Familiarity with quality control and quality assurance processes in a laboratory setting. Knowledge of regulatory guidelines (e.g., FDA, EMA) related to microbiological testing. Proficient in using laboratory information management systems (LIMS) and relevant software...SuggestedFull time
- ...we’re building a SaaS platform that revolutionises process efficiency for product development, quality, and operations teams in ISO and FDA regulated companies, especially in the medical device, pharmaceutical, nutritional supplement, and cosmetics industries. By...SuggestedFull timeHybrid workWork at officeImmediate start
- ...needed The key skills required are as follows: IT Quality, Regulatory, Compliance (IT-QRC) Quality guidelines mentioned by FDA, MHRA, and other regulatory bodies GxP practices and GAMP5 guidelines. Computer System Validation of various COTS products...SuggestedFull time
- ...EMG Biofeedback, with operations across India, the USA, Canada, and Malaysia. Recognized for innovation and global partnerships, JOGO is FDA-cleared, JCI-accredited, and collaborates with leading institutions like Harvard Medical School. Job Overview Join JOGO Health Pvt...SuggestedFixed term contractImmediate start
- ...capabilities. The companys more than 60000 employees serve clients in over 100 countries worked on over 80% of the new drugs approved by the FDA in 2022 and performed more than 600 million tests for patients around the world. Global Internship Program: Exciting opportunity...SuggestedFull timeInternshipWorldwide
- ...Author and review technical documentation, validation protocols, and reports. Ensure compliance with global regulatory standards (FDA, EMA, WHO). Mentor and train operators and technical staff. Qualifications ~ Bachelor’s/Master’s in Pharmacy, Biotechnology, Chemical...SuggestedFull time
- ...of experience in regulatory affairs preferably with QA (Quality Assurance) and PV experience Skills & attributes: Knowledge of FDA EMA/EM guidelines. Proficiency in spoken and written English. Proficiency in using a computer and its applications specifically...SuggestedFull timeRemote job
- ...metal exp in Stack-up analysis. Regulatory compliance alignment knowledge including ISO 13485 IEC 60601 ISO 14971 Understanding of FDA design control requirements (21 CFR 820.30). Working experience in EUMDR requirements ( Gap assessment and remediation)....SuggestedFull time
- ...Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with...SuggestedFull timeContract work
- ...management ~ Business/financial acumen ~ Six sigma and process excellence tools/methodologies ~ Presentation skills ~ Knowledge of FDA and other regulatory guidance preferred. ~ Proficiency in Microsoft MS Office is required ~3D Modeling Software experience...SuggestedFull time
- ...certification (preferred but not required). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter...SuggestedFull timeContract work
- ...Compliance & Documentation Ensure compliance with relevant quality and regulatory standards (e.g. ISO 9001 Six Sigma CMMI SOC 2 FDA or similar frameworks). Prepare and maintain quality documentation test reports and audit records. Lead or support internal and external...SuggestedFull timeRemote jobShift work
- ...validation activities for GxP-regulated computerized systems. The ideal candidate will ensure compliance with global regulatory standards (FDA EMA MHRA) and support cross-functional teams in implementing and maintaining validated systems across the pharmaceutical lifecycle....SuggestedFull timeWorldwide
- ...submissions. Interprets and applies key regulatory guidance regional submission specifications and evolving eCTD requirements (including ICH FDA EMA etc.). Leads and contributes to the development revision implementation and training of departmental SOPs WIs and standardized...SuggestedFull time
- ...What are the professional and personal opportunities for development within this role Exposure to global regulatory frameworks (FDA EU MDR ISO standards) Opportunities for international collaboration and cultural exposure From Health and wellness programs to Work...SuggestedFull timeWork at office3 days week
- ...respond to queries from regulatory authorities. Ensure formulation development complies with regulatory guidelines and standards (e.g., FDA, EMA, ICH). Required Qualifications & Skills Educational Qualification : B. Pharm / : M. Pharm in Pharmaceutics Experience...Full time
- ...improvement efforts. Youre the right fit if: Youve acquired a minimum of 14 years experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. Bachelors/Masters Degree in Engineering in a related field You have proven expertise in...Full timeWork at office3 days week
- ...or related Life science discipline required with relevant experience in the pharmaceutical industry. Mandatory Knowledge of ICH and FDA guideline for US market. Working knowledge of eCTD/ CTD/NEES types of submission industry standard publishing systems. Should be...Full time
- ...Familiarity with competitor flow cytometry systems (BD Cytek Beckman Coulter etc.). Exposure to regulated testing environments (ISO FDA or GLP) and quality documentation processes. Experience working in Agile or hybrid software development settings. Interest in using...Full timeHybrid workWork at officeWorldwideWorking Monday to Friday
- ...payments. Support Strategic Sourcing Initiatives: Assist in data collection for cost supplier audits internal audit for ISO IATF FDA Contribute to localization and dual sourcing projects under guidance. Qualifications & Skills: ~ Bachelors degree...Full timeShift work
- ...Work collaboratively with cross-functional teams to define requirements and resolve technical challenges. Ensure compliance with FDA 21 CFR 820.30 Design Controls FDA Cybersecurity in Medical Devices and IEC 62304 Software in a Medical Device. Participate in code reviews...Full timeWorldwide
- ...agentic frameworks (LangGraph LangMem) Strong Azure cloud platform Secondary skill Claude Code pharmaceutical regulatory requirements (FDA EMA ICH guidelines) Job Description AI Engineer to implement intelligent automation workflows for pharmaceutical analytical...Full time
- ...and CSA adoption. Contribute to team training peer review sessions and development of reusable playbooks. Stay updated on evolving FDA and EMA guidance related to CSV CSA and digital quality transformation. Skills Preferred: ~ Technical / Domain Strong...Full time
- ...productivity improvement. Other Job-Related Skills/Background Advanced knowledge of MS-Word MS-Excel MS-PowerPoint. Certification from FDA for Competent Technical Staff ( recommended). Excellent communication skills and the ability to build relationships at all levels...Full timeContract workLocal areaWorldwideShift work
- ...performance. Regulatory Compliance: Ensure all packaging designs and materials comply with global regulations and standards, including US FDA, EU MDR, and other relevant guidelines. Prepare necessary documentation for regulatory submissions (e.g., specifications, master...Full time
- ...development activities including client engagement proposal support and solutioning. Solid understanding of GxP regulations including FDA 21 CFR Part 11 and EU Annex 11. Ability to contribute to thought leadership offering innovative insights and best practices in Vault...Full time
- ...analytical ability Good working knowledge of medical terminology statistical concepts GCP guidelines (e.g. ICH) and requirement of the FDA and other international regulatory agencies Detail oriented thorough and methodical Proficient grammatical and communication...Full timeWork at officeWorking Monday to Friday
- ...technical teams for system enhancements interface design and data migrations. Support compliance and regulatory requirements (e.g. FDA REACH GxP) by configuring PLM workflows. Stay updated on the latest PLM capabilities innovations and industry best practices....Contract workHybrid work
- ...Skills & Attributes Exposure to business development activities and client engagement strategies Exposure to regulatory compliance (FDA EMA) and audit remediation. Ability to create innovative insights and contribute to thought leadership Experience in process...Full timeWorldwide
- ...new drug applications, variations, renewals, and amendments. Manage regulatory submissions to authorities such as CDSCO, DCGI, US FDA, EMA, MHRA , or other global health authorities, as applicable. Ensure compliance with applicable regulatory guidelines, standards,...Full timeWeekday work