Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.
Role & responsibilities Recruitment and Onboarding: Employee Relations and Performance Management Managing employee data and records Sourcing and screening candidates Payroll management Preferred candidate profile
Dear Candidate, BioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP and EU-GMP also complies with ANVISA , UKMHRA , and USFDA regulations. With a significant presence in Europe, African and CIS regions, we export our products to over 30+ countries . We have over 1000+ product registrations with more than 450+ products under registrations. We are inviting Hardworking and dedicated Candidates to be part of our team for our ongoing expansion of EU/LATAM/GCC/SEA regions. Department: Purchase/ Procurement /PPMC Experience : 2-7 Years Location: Thaltej, Ahmedabad. Roles and Responsibilities Manage procurement activities for finished products from third parties, ensuring timely delivery and quality standards. maintain 3rd party vendor for finished product purchase Develop and maintain relationships with vendors to negotiate prices, terms, and conditions. Plan and execute purchase operations to meet business requirements while minimizing costs. Conduct buyer activities such as material procurement, vendor development, and new vendor identification. Ensure compliance with company policies, procedures, and regulatory requirements.
Roles and Responsibilities Conduct analytical method validation, including preparing methods, running samples, and reporting results. Perform routine maintenance of laboratory equipment such as GC-MS, HPLC, LCMS, and other chromatography systems. Develop and maintain calibration protocols for instrument qualification and preventive maintenance schedules. Collaborate with cross-functional teams to resolve issues related to analytical testing and method development. Ensure compliance with regulatory requirements by maintaining accurate records of test data and reports.
-Plan, prepare and review of high-quality eCTD dossier within stipulated timelines for submission in regulated markets like EU/Australia/Canada/UK/ South Africa. -Preparing query responses for submission to regulatory agencies and clients, within the stipulated timelines. - Preliminary review of the In-licence dossier and preparation of the due diligence report. -Co-ordination with cross-functional teams at manufacturing plant and RnD for retrieving documents and any matters related to the submission. -Technical review of GMP documents and RnD documents for submission purpose. -Hands on experience with eCTD software and be able to compile eCTD sequence for EU/Australia/Canada/UK/ South Africa markets. -Exhibiting good and up-to-date knowledge of ICH/EMA guidelines and regulations for submission in the regulated markets of EU/Australia/Canada/UK/ South Africa. -Ensuring product compliance throughout its lifecycle via any necessary post approval regulatory notifications/variations. -Monitoring and interpreting regulatory guidelines and staying up-to-date with evolving legislation and guidelines. -Should have good verbal and written communication skills. -Should have a positive attitude and be a team-player. - Note - Candidate can also call on 6357410551-Bhargav Dalal- HR.
Job description Banking & Finance and working capital management Finalization of Accounts, Preparation of Financials and related documents MIS preparation and data preparation and presentation for the management Statutory Audit, GST, Income Tax, TDS, ROC, other statutory compliances Insurance related portfolio Accounts Payable activity Should do supervision, evaluation in ERP related to departmental functions Should train, educate and lead the team Resolving different types of deductions like Freight damage, Inventory price adjustment Required experience in accounting entries i.e., sales/purchase/cash/bank/JV. Experience in ERP, SAP added advantage Should be vigilant and have adequate analytical skills Interested candidate can share cv on WhatsApp - 9725901031
FIND ON MAP