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0.0 - 5.0 years
1 - 3 Lacs
dahej
Work from Office
Interview for QA Officer & Ex on 15-11 in Bharuch For Chemical Co Bsc/Msc Chemistry Fresher to 4 yr Male/ Female 5.5 LPA Apply : sdpbharuch@gamil.com sub : QA Dahej Required Candidate profile Interview Venue: SDP HR Solution, 610, Golden Square, Beside DMART, Near ABC Circle, Bholav, Bharuch - 392001
Posted 1 month ago
2.0 - 6.0 years
6 - 7 Lacs
mumbai, navi mumbai
Work from Office
Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports. Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review. Under management s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement to gain experience. Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidance s to understand and accurately assess change controls. When needed, train Associate I s on internal processes, procedures, databases and trackers. Other projects and duties as ...
Posted 1 month ago
3.0 - 4.0 years
2 - 3 Lacs
ahmedabad
Work from Office
Manage end-to-end HR operations- recruitment, onboarding, payroll, and exits Handle attendance, leave, and other activities Working Days: 6 days/week (2nd & 4th Saturday Off),Timings: 10:00 AM – 7:00 PM, Joining: Immediate
Posted 1 month ago
5.0 - 8.0 years
7 - 10 Lacs
bengaluru
Work from Office
BIOS UEFI and Coreboot Bangalore 5 to 8 years Semicon-Embedded Design,Embedded SW Experience in the x86 BIOS/UEFI development Experience with x86 CPU/APU architectures and associated compilation tools Expert in C language Experience with platform bring-up. Familiar with at least one BIOS code base (AMI, Insyde, or Phoenix BIOS) Experience of working with opensource coreboot project & mainboard related porting. Experience of working with Intel FSP codebase and understanding of coreboot & FSP boot flow. Understanding of coreboot & FSP build tools and build processes. Experience of working with different coreboot payloads like edk2, SeaBios, Tianocore etc Ability to read platform Hardware and P...
Posted 1 month ago
6.0 - 11.0 years
9 - 13 Lacs
bengaluru
Work from Office
RSM is looking for a dynamic Manager to join our Assurance team. You will have the opportunity to work as a team member on diverse client engagements. Our clients include local, national and internationally recognized companies. RSMs assurance professionals helping companies improve their performance through the most challenging business cycles. Responsibilities Perform Review and Compilation engagements in accordance with firm and professional standards as directed by engagement leaders. Design, develop, and execute analytical procedures to assess financial data and performance metrics. Review and analyze lease agreements to ensure compliance with lease accounting standards (e.g., ASC 842),...
Posted 1 month ago
4.0 - 8.0 years
8 - 11 Lacs
ahmedabad
Work from Office
Seeking a Regulatory Affairs professional (5–12 yrs exp, US FDA focus) to manage product approvals, ensure compliance, and liaise with regulatory bodies. B.Pharm/M.Pharm required.
Posted 1 month ago
10.0 - 13.0 years
4 - 9 Lacs
bhuj
Work from Office
Hiring For Civil Manager For Chemical Co in Bhuj/Kutch Location BE Civil 10 TO 15 YR EXP 12.0 LPA Apply : sdpbharuch@gmail.com Sub: Civil Manager Kutch Only Chemical Co Experience Prefer Free Requirement Required Candidate profile SDP HR Solution 611, Golden Square, Beside DMART, Near ABC Circle, Bholav, Bharuch
Posted 1 month ago
3.0 - 6.0 years
4 - 8 Lacs
bengaluru
Work from Office
Responsibilities Extensive experience in bookkeeping, financial statement preparation, compilations, reviews, and Canadian tax compliance. Prepare corporate income tax returns for Canadian clients (T2), partnership returns and other tax slips. Develop and apply knowledge of International Financial Reporting Standards (IFRS), Generally Accepted Accounting Principles (GAAP) and/or Accounting Standards for Private Enterprise (ASPE) Develop an understanding of the client's business, and become an industry specialist to understand client specific needs Understand and utilize RSM's audit, review and compilation methodologies Function as in-charge facilitating client work by monitoring and reportin...
Posted 1 month ago
6.0 - 11.0 years
8 - 12 Lacs
bengaluru
Work from Office
RSM is looking for a dynamic Manager to join our Assurance team. You will have the opportunity to work as a team member on diverse client engagements. Our clients include local, national and internationally recognized companies. RSMs assurance professionals helping companies improve their performance through the most challenging business cycles. Responsibilities Preparing financial statements, conducting compilations and reviews, and completing Canadian corporate tax returns. Perform Review and Compilation engagements in accordance with firm and professional standards as directed by engagement leaders. Design, develop, and execute analytical procedures to assess financial data and performanc...
Posted 1 month ago
3.0 - 6.0 years
4 - 8 Lacs
bengaluru
Work from Office
Responsibilities: Extensive experience in bookkeeping, financial statement preparation, compilations, reviews, and Canadian tax compliance. Prepare corporate income tax returns for Canadian clients (T2), partnership returns and other tax slips. Develop and apply knowledge of International Financial Reporting Standards (IFRS), Generally Accepted Accounting Principles (GAAP) and/or Accounting Standards for Private Enterprise (ASPE) Develop an understanding of the client's business, and become an industry specialist to understand client specific needs Understand and utilize RSM's audit, review and compilation methodologies Function as in-charge facilitating client work by monitoring and reporti...
Posted 1 month ago
3.0 - 5.0 years
4 - 9 Lacs
ahmedabad
Work from Office
Looking for Embedded Software professional who is technically strong and has hands on experience in Programming Language (C/C++), Linux Kernel, BSP and Device drivers Candidate should have been involved in development of at least 2 3 different device drivers for Linux Experience with board bring up, device driver, porting, bootloader, u-boot, file systems are required The candidate should be ready to travel and work at customer locations as per project requirements Responsibilities Requirement understanding, Design, Develop, integrate, unit testing & debugging of Embedded Software Real-time applications, Device Drivers, Bootloader, porting, firmware development, Linux kernel etc. Documentati...
Posted 1 month ago
3.0 - 5.0 years
3 - 7 Lacs
ahmedabad
Work from Office
Looking for a creative and highly motivated Embedded Software Engineer with hands-on experience in Multimedia. The role also requires hands-on experience with Multimedia HAL frameworks and subsystem drivers for Linux, with strong proficiency in C/C++ on Linux. Responsibilities Design, Implement & Build solutions using Multimedia processing techniques. Deliver on market relevant use-cases on any of SoC/GPU/DSP/CPU platforms. Customize/Optimize Multimedia pipelines for a particular target hardware. Bring-up and development of multimedia drivers, libraries and applications. Debugging and development on Linux Kernel media subsystem drivers and customer issues. Debugging and development on media ...
Posted 1 month ago
3.0 - 8.0 years
4 - 9 Lacs
ahmedabad
Work from Office
Role & responsibilities We have opportunity in Regulatory Affairs for Emerging Markets Position: Officer/Executive/Assistant Manager Regulatory Affairs Experience: 3-6 Years and 8+Years for Assistant Manager Qualification: B.Pharm/M.Pharm Location: Ahmedabad 1. Compilation of dossiers in CTD, eCTD & national formats 2. Compilation and submission of Queries Response and Variation Filing. 3. Review of documents, artworks 4. Review of change controls 5. Gap analysis for new product filing 6. Maintaining product Life cycle Candidates having experience LATAM/CIS/ Africa/Asean or any other Emerging Markets can apply
Posted 1 month ago
8.0 - 13.0 years
25 - 30 Lacs
pune
Work from Office
POSITION DESCRIPTION: The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients The RA specialist will work with clients in India and globally across USA and Europe to provide solutions for getting approvals for their products for launch in the Europe and USA The candidate will require to go through extensive training in various country specific regulations as needed to keep themselves up-to-date with the latest and greatest updates as well as represent IZiel at ...
Posted 1 month ago
5.0 - 9.0 years
4 - 7 Lacs
gurugram
Work from Office
Responsibilities: * Prepare regulatory dossiers for product approvals * Collaborate with cross-functional teams on dossier updates * Ensure compliance with drug regulations according to NAFDAC standards. * Manage LOAs, COAs & BDNAF submissions
Posted 1 month ago
2.0 - 5.0 years
2 - 5 Lacs
vadodara
Work from Office
1. Regulatory Submissions & Approvals: Prepare, review, and submit drug regulatory dossiers (e.g., Formulations, APIs, supplements) to CDSCO, state FDA, and other authorities . Follow up on approval status, queries, and responses with regulatory bodies. Maintain trackers of pending applications, renewal dates, and approvals . 2. Documentation & Compliance: Ensure preparation of regulatory documents, SOPs, product labeling, packaging inserts, and promotional materials in compliance with regulatory norms. Maintain accurate records of regulatory correspondence, approvals, and submissions . Support internal audits and inspections with regulatory documentation. 3. Product Lifecycle Management: Mo...
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
navi mumbai, maharashtra
On-site
As a Regulatory Affairs Specialist in our company, your role will involve the following key responsibilities: - Ensuring timely response to deficiencies raised by Agency on ANDAs. - Reviewing all specifications and proposals from sites of approved ANDAs for supplement filings. - Providing regulatory support and reviewing pre-filing and development documentation such as development reports, BMR, BPR, specifications, method validation, process validation, change control, etc. - Authoring, compiling, and reviewing ANDA dossier in eCTD format and structured product labeling (SPL), followed by publishing, validation, and submission of the dossier. - Submitting PADER to comply with USFDA requireme...
Posted 2 months ago
2.0 - 6.0 years
0 Lacs
kochi, kerala
On-site
As a candidate for this position, you will be responsible for various tasks related to sales operations and financial analysis. Your key responsibilities will include: - Collecting daily reports and feedback from the team, and organizing them in specified formats. - Compiling stock and sales statements. - Tracking the field activities of the Sales team regularly. - Providing timely feedback to the Sales team and Managers, in consultation with the Manager. - Scrutinizing expenses and ensuring timely reimbursement. - Managing stock of wholesalers by placing timely orders after consulting with the manager and GetMedGo. - Tracking and filing GST. - Conducting financial analysis. To qualify for t...
Posted 2 months ago
3.0 - 5.0 years
4 - 4 Lacs
mau, thane, raigarh
Work from Office
KEY RESPONSIBILITIES: Support district in finalization of target geography. Conduct Vulnerability mapping at quarterly interval Submit mapping report to state on a regularly basis. Support ORW in health camp planning Assess supplies required for implementation of activities Supervise district level implementation of all activities Ensure daily report is being submitted in time in case activity happening Support district in assessing supplies and forecasting of requirements Support district in procurement Ensure samples are transported to designated labs Conduct service and supply mapping before every activity Ensure health camps are organized as per plan Support community level team in devel...
Posted 2 months ago
5.0 - 10.0 years
9 - 13 Lacs
bengaluru
Work from Office
RSM is looking for a dynamic Manager to join our Assurance team. You will have the opportunity to work as a team member on diverse client engagements. Our clients include local, national and internationally recognized companies. RSMs assurance professionals helping companies improve their performance through the most challenging business cycles. Responsibilities Perform Review and Compilation engagements in accordance with firm and professional standards as directed by engagement leaders. Design, develop, and execute analytical procedures to assess financial data andperformance metrics. Review and analyze lease agreements to ensure compliance with lease accountingstandards (e.g., ASC 842), i...
Posted 2 months ago
5.0 - 8.0 years
5 - 9 Lacs
bengaluru
Work from Office
Responsibilities Extensive experience in bookkeeping, financial statement preparation, compilations, reviews, and Canadian tax compliance. Prepare corporate income tax returns for Canadian clients (T2), partnership returns and other tax slips. Develop and apply knowledge of International Financial Reporting Standards (IFRS), Generally Accepted Accounting Principles (GAAP) and/or Accounting Standards for Private Enterprise (ASPE) Develop an understanding of the client's business, and become an industry specialist to understand client specific needs Understand and utilize RSM's audit, review and compilation methodologies Function as in-charge facilitating client work by monitoring and reportin...
Posted 2 months ago
6.0 - 11.0 years
5 - 11 Lacs
ahmedabad
Work from Office
Sakar Healthcare Ltd incorporated in 2004 has emerged as a leading pharmaceutical manufacturer based in Western India, specialized with innovative oncology solutions. With the research-driven API-integrated EU GMP approved oncology orals & injection formulation manufacturing units, Sakar is ready to cater the global markets with diverse product range and business models. Mentor regulatory team of 12, conduct training sessions on the latest regulatory updates have experience of trouble shooting with good communication skills client handling. Preparing/ checking and submitting technical files and compilation of dossiers in CTD format of Product life-cycle management in ROW & EU markets. Ensuri...
Posted 2 months ago
3.0 - 5.0 years
9 - 14 Lacs
mumbai
Work from Office
HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline, About The Role Key Responsibilities Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate ind...
Posted 2 months ago
1.0 - 5.0 years
0 - 3 Lacs
pune
Work from Office
Position : Sr Officer Minimum Qualification : M.Sc. / M.Tech. in Molecular Biology, , Biotechnology, Microbiology, or related life sciences. Mandatory Skills : Hands-on experience in molecular biology techniques, enzymes and protein chemistry. Hands-on experience in microbial techniques and fermentation Ability to perform experiments, compile the data, analyse results. Experienced in reaction downstream processing, product isolation, purification, characterisation, etc. Work safety practices are mandatory. Industry type : Academics/Biotech/ Pharma/ nutraceutical industry/Diagnostic
Posted 2 months ago
2.0 - 5.0 years
2 - 5 Lacs
navi mumbai, india
Work from Office
Job Description Position Summary We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval Key Responsibilities: Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets. Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific). Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, E...
Posted 2 months ago
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