7 Ich Guidelines Jobs

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station. Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Perks and Benefits: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

Job Description We are looking for a dedicated and enthusiastic individual to join our Analytical Development team. The ideal candidate will contribute to maintaining high-quality standards in analytical research and support the development of safe and effective pharmaceutical products for global markets. This role offers hands-on experience in method development, validation, and regulatory documentation within a dynamic R&D environment. RESPONSIBILITY : Assisting to Team leaders, Research Scientists of Analytical Development departments on Research work and daily basis activity. Work towards Analytical development, Validation, Transfer activities of oral solids, Oral Liquids, Parenteral and semisolid products for Regulatory & ROW markets. Responsible to assist the major activity like Analytical method development, Routine and Stability sample Analysis, Method Verification/Validation and Method Transfer Activities. Conduct all Analytical activities associate with Research Scientist and seniors. Maintain good Hygiene, Clean of Laboratory and Follow Good Laboratory Practices. Scientific literature Search for strategic development towards Analytical developments. Review and summarizing technical data for milestone achievements. Responsible for Preparation of Analytical Reports like protocols, reports and other documentations, Maintain Quality documents of overall R&D Documentation Practices. Maintain Analytical Laboratory Note book during Analysis. Should be conversant of the ICH guidelines for stability studies of products and formulations. Accountable for the safety of Analytical Laboratory including maintenance of an effective Chemical Hygiene Plan. Accountable for SOP preparation of Analytical Instruments and GLP Procedures. Accountable of Maintance and proper storage of Laboratory chemicals, reagents, standards, impurities and other articles. Maintain Evolet Healthcare Policy on Quality, Saftey and Efficacy Value. Candidate Requirements: Qualification : M. Pharmacy or PhD in Pharmaceutics or related field Experience : 0 to 2 years in Research Associate (Analytical & Development) Communication Skills : Excellent verbal and written communication skills in English Attributes : Positive attitude, willingness to learn, and a proactive approach to research work

We are looking for passionate and motivated individuals with an M. Pharmacy or PhD qualification to join our dynamic Research & Development team as a Research Associate (Formulation & Development). As a Research Associate, you will be actively involved in formulation development for various dosage forms, supporting scientists in innovative pharmaceutical research for both regulatory and ROW markets. Job Description: Assisting to Team leaders, Research Scientists of Formulation & Development on Research work and daily basis activity. Work towards formulation development of oral solids, Liquids, Parenteral and semisolid products for Regulatory & ROW markets. Conduct product development activity associate with Research Scientist and seniors. Conducting Experimental Trials, and maintain daily basis documentation on Research Activity. Maintain good Hygiene, Clean of Laboratory and Follow Good Laboratory Practices. Scientific literature Search for strategic development towards formulation developments. Maintenance and Reconciliation of All API, RM, PM and R&D Store Materials. Provides support in scale up/Technology transfer activities for new Formulation development Projects. Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.) Review and summarizing technical data for milestone assessments. Preparation & Reviewing of formulation development protocols, reports and other documentations, Maintain Quality Documents of overall R&D Documentation Practices. Maintain Laboratory Note book during conducting trials. Should be conversant of the ICH guidelines for stability studies of products and formulations. Candidate Requirements: Qualification : M. Pharmacy or PhD in Pharmaceutics or related field Experience : 0 to 2 years in Formulation & Development or related R&D activities Communication Skills : Excellent verbal and written communication skills in English Attributes : Positive attitude, willingness to learn, and a proactive approach to research work Technical Understanding : Basic knowledge of formulation development processes and good laboratory practices (GLP) is desirable

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station. Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Perks and Benefits: Health Insurance Shuttle facility, Fix office timing, Career growth training & development

1. COA/ Certificate of Analysis 2. MSDS 3. Specifications/ TDS 4. Method of Analysis 5. Stability Data 6. DMF/ Drug Master File 7. Declarations B. Preparation of Vendor Questionnaire Required Candidate profile C. Customer response for technical queries D. Must have knowledge of Pharmacopoeias, ICH guidelines Intrested Candidate Can connect on 91-9724346949 / 9327657730

About Us We are a specialty chemicals manufacturing company with a full stack solution from R&D to manufacturing and doorstep delivery of innovative chemicals. Headquartered in Bengaluru, India we cater to pharmaceutical, agrochemical, personal care, and home care industries. Our B2B fulfillment platform supports businesses globally in developing and manufacturing chemicals from lab to commercial scale. With a team of in-house R&D experts and scientists, we offer custom synthesis and route scouting services to support manufacturers in product development. We are VC backed - here are a few reads . We are 150 people strong and have offices in India, UAE and Indonesia. We are currently exporting to over 13 countries from India currently. Job Description: Executive Research Chemist As we work towards establishing our presence globally we are looking to hire a leader to build and expand the business and team there. Key Responsibilities Prepare STP, COA, Reference Standards, and SOPs. Archive and maintain regulatory documents as per compliance. Review daily calibration data, STP, COA, IQ, OQ documents. Conduct daily lab audits to ensure SOP adherence. Ensure compliance with ICH guidelines and US/EU regulatory requirements. Qualifications 2 years of relevant experience into pharma industry. Msc in Pharmaceutical Quality Assurance. Strong knowledge of pharma quality assurance practices. Detail-oriented with excellent documentation and review skills. Familiarity with global regulatory standards. If you are a startup enthusiast and like working with fast paced and high growth teams, join the team. To explore synergies email your coordinates/ resume on careers@scimplify.com

(2 -4) Years of Work Experience in regulatory. WHO Collaborative countries having knowledge of Regulatory guideline viz ICH, EMEA , PIC.