Average salary: Rs3,249,999 /yearly
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Rs 25 - 40 lakhs p.a.
...Job Description Job Title: Head - FDA Sales Company: Department: Sales & Marketing Reporting To: Director - FDA Location: Gurgaon (WFO) CTC: ₹25-40 LPA Employment Type: Full-time About Antal Antal International, East...SuggestedLong term contractFull timeAntal International Network
Gurgaona month ago- ...Programmer. ERP: JD Edwards Enterprise One (versions from XE to 9.2). Media Objects, Table triggers, UDC, NER, C/C++ BSFN, UBE's, FDA, RDA, OMW, Power Forms, DEBUG, DEBUG C, EDIS, Log interpretation. Programming Languages: JDE Toolkit, C, C++, PL/SQL. Agile...SuggestedFull time
- ...PromoMats and RIM, ensuring consistency with naming conventions, taxonomy, and version control requirements. Knowledge of compliance and US FDA regulatory requirements for promotional materials in the pharmaceutical or life sciences industry. Experience troubleshooting and...SuggestedRemote jobFull time
- ...and apply key IP regulations including India’s Patents Act, U.S. Patent Act, DMCA, Trade Secrets Protection Acts, HIPAA, DPDP, GDPR, and FDA/CDSCO frameworks. Transactions Support IP due diligence for mergers, acquisitions, funding rounds, and strategic partnerships in...SuggestedWork at officeImmediate start
- ...authoring and review of all Qualification documents as per USFDA / Annex- guidelines • Excellent knowledge of cGMP standards and relevant EU/FDA regulations • Complete ownership of full validation cycle process implementation and associated documentation • Understanding of...SuggestedFull time
- ...and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled...SuggestedContract workWorldwideFlexible hoursNight shift
- ...019 and Biotek SOPs. D. Regulatory Support · Support preparation of technical documentation for regulatory submissions (CDSCO, US FDA, EU MDR). · Prepare CER (Clinical Evaluation Report), PMCF plans/reports, summary of safety & clinical performance (SSCP). · Provide...SuggestedFull timeContract workInterim role
- ...governance forums. ~Lead safety signal evaluation, escalation, and documentation. ~Ensure compliance with global safety regulations (FDA, EMA, ICH, CIOMS, local health authorities). ~Partner with team lead for regulatory interactions, inspections, and audits. ~Author or...SuggestedLocal areaRemote job
- ...years of leadership/management experience • Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP, NABL/ISO 17025) • Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)...SuggestedRemote jobFull timeWork at officeWorking Monday to Friday
- ...to provide leadership with insights into business performance, system health, and operational metrics. ~Ensure all systems comply with FDA regulations, GDPR, and other biotech-related regulatory standards. ~Develop system validation documentation and manage validation...SuggestedFull timeHybrid workRemote job
- ...knowledge of Indian medical device regulations (CDSCO - Central Drugs Standard Control Organization), ISO 13485, and global standards such as FDA 21 CFR Part 820. Experience with implementation and maintenance of ISO 13485 certification and regulatory audits (CDSCO, US FDA, EU...Suggested
Lubrizol Lubrizol Corporation
Mumbai28 days ago - ...Services to align training with launch readiness and lifecycle strategy. ~Ensure all training materials and certification processes meet FDA, EMA, and global compliance standards. ~Implement structured field excellence programs focused on high quality and impactful...SuggestedRemote job
- ...quality and compliance with hands-on validation experience on enterprise applications (LIMS, ERPs, LMS, RPA, CTMS, etc.). Experience in FDA-regulated environments with a good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation. Experience with...SuggestedLong term contractImmediate start
- .../pharmacovigilance, manufacturing, supply chain, medical affairs, quality). ~Ensure compliance with regulatory and quality standards (FDA, EMA, ICH-GCP, relevant local regulations) and internal SOPs. ~Participate in protocol development and amendments, informed consent form...SuggestedLocal areaRemote job
- ...biotechnology • Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field • ISO 13485/FDA Lead Auditor certification beneficial • ASQ certification (CQE, CQA) advantageous • Knowledge of quality systems, cGMP regulations,...SuggestedRemote jobFull timeWork at officeAfternoon shift
- ...Knowledge of clinical trial processes, statistical methodologies, CDISC standards (SDTM, ADaM), and regulatory submission requirements (e.g., FDA, EMA). Demonstrated expertise in implementing and overseeing data management, statistical programming, and biostatistical analysis...Full timeContract workHybrid work
- ...across regions. Desirable Skills/Experience Regulatory expertise: Legal and Compliance background with deep knowledge of PhRMA Code, FDA/OIG guidance, ABAC, GDPR, and global/country-specific compliance and transparency requirements. Functional breadth: Prior experience...Full timeContract workHybrid workWork at officeFlexible hoursShift work3 days week
- ...Exposure to business development activities, including client pursuits and RFP support. Familiarity with regulatory compliance frameworks (FDA, EMA) and audit remediation. Experience in process optimization and operational efficiency initiatives. PMP Certification...Full timeWorldwide
- ...considered should this role become available. 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...Contract work
- ...records as per GDP in physical as well as in SAP. 8. Generate & analyze production MIS on monthly basis. 9. Ensure compliance to FDA & ISO guidelines. 10. Comply with safety and environmental requirements. 11. Responsible for handling audits and coordinating with...Shift work
- ...organizational and time management skills. To be successful in this position it is important to have strong knowledge of regulatory guidelines (FDA/CFR; ISO14155).Motivated, self-starter with the ability to work with minimal supervision, Technical aptitude, attentiveness to detail,...Full time
- ...low. This is a largely sedentary role. 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 what...Contract workWork at office
- ...becoming the subject matter expert (SME). 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...Full timeContract work
- ...perform the essential functions of the job. 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...Contract workLocal area
- ...Experience working in the biopharmaceutical, device, or contract research organization industry required. ~ Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required. ~ Experience writing relevant...Full timeContract work
- ...recruitment and employment of its employees. 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...Contract workLocal areaRelocationWork visa
- ...considered should this role become available. 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...Full timeContract workWork at officeWork from homeShift work
- ...write, speak, and understand English. 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...Full timeContract work
- ...development and tracking and audit/inspection preparation. Knowledge of PV vendor management. Familiarity with global PV regulations (FDA, EMA, ICH). Experience in clinical trial and post‑marketing PV. Strong communication, problem‑solving, and organizational skills....Remote jobFull timeFixed term contract
- ...considered should this role become available. 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...Full timeContract workFlexible hours
