2122 Regulatory Affairs Jobs - Page 24

Development of Lyophilized Complex/Peptide Injectable & Biosimilar Product Development (Thaw, filter, fill & Finish). Drug Product R&D Stability, Compatibility & Development Studies. Participate in scale-up, toxicity/clinical exhibit batches of the Drug Products under development. Authoring regulatory filling & TTD Documents i. e. MF, RA, PDR, Stability Study Plan & R&D Stability Studies. Travel Estimate NA Job Requirements Educational Qualification M. Pharm - Pharmaceutics Experience Tenure : 2-6 years

Job description for Executive / Officer - Regulatory Affairs Department (USA market) Location: Nivagen Pharma (INDIA) Pvt. Ltd., Satellite, Ahmedabad, INDIA Report to : Manager, Regulatory Affairs, Nivagen Pharmaceuticals Job Description: 1. Compilation of various applications like CC / CGT / iPSP / PIND packages. 2. The planning, writing and review of all regulatory submissions to support PIND/IND/NDA/505(b)2/ANDA/PAS submissions including FDA meeting requests and technical DS, DP and Clinical packages. 3. Compilation and review of Labeling and SPLs for NDA/ANDA/PAS applications. 4. Review and compilation of DMF sections for NDA/ANDA/PAS filing. 5. Ensures that project timelines are develop...

Greetings!!! We are looking for RA Executive - Formulation Injectable for a leading pharma company at Chennai Key Responsibilities: Preparation & review of regulatory documents, technical dossiers, and official communications. eCTD filing for submissions across various regulatory authorities. Handling applications/renewals for Import & Test Licenses. Coordinating with QA, QC, AR&D, and other teams for submissions. Reviewing registration dossiers for accuracy & compliance. Preparing & filing ANDA and ROW market submissions. Desired Skills: Strong documentation & communication skills. Attention to detail, ability to manage multiple submissions. Experience in injectables regulatory affairs pref...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! The candidate will be an integral part of the AskHR team, a high-touch and customer-focused function within BMC HR. The candidate is expected to deliver an exemplary employee experience with every interaction. Candidates needs to be approachable, customer focused, flexible, action-oriented, and innovative along with great verbal and written communication skills. They should have great attention to detail while supporting a broad range of HR activities including data management, benefits administration, offboarding and...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

Your role and responsibilities Play key role in Project Controlling, financial analysis, closing activities including audits, reporting of the division and support project management team in all financial and commercial matters and actively drive the projects performance. The work model for the role is: #Li - Onsite This role is contributing to Motion Traction Division in Bangalore/Vadodara. You will be mainly accountable for: Supports the tender manager and Project Manager on financial aspects. Provides input to negotiations on commercial issues. Provides input in local risk review process. Provides input to the Project Execution Plan on financial aspects. Prepares project invoices, financi...

Yes, I understand the job description completely. Here is a summary of my understanding: Role: Regulatory Affairs Manager Level: Mid to Senior Location: Gurgaon, India (with a hybrid work model) Salary 6-9 LA The Core Purpose of the Role: We are looking for a regulatory expert to ensure their productsspecifically food, nutraceuticals, and agricultural inputs (like fertilizers)are legally compliant in India and for export markets, with a focus on the U.S. and EU. This person will be the central point of contact for all regulatory matters, both internally and with external authorities. Key Responsibilities Breakdown: Compliance Management: Manage all regulatory requirements for the company's d...

Key Responsibilities: Design, develop, and execute behavioral and technical test cases for systems, applications, or products. Analyze requirements and user stories to create comprehensive test strategies. Conduct manual and/or automated testing as needed. Identify, log, and track defects or issues , and work with development/engineering teams for resolution. Validate system behavior under different conditions (e.g., performance, stress, usability). Participate in review meetings to provide test updates and insights. Maintain test documentation , including test plans, test cases, and test reports. Ensure compliance with quality standards and best practices in testing. Collaborate with cross-...

Compilation and submission of eCTD dossier for new product application & post approval submission Query response, PAS,CBE and annual report, drug listing Review of artwork and submission of labelling section Maintain product life cycle.

Regulatory Affairs Associate Experience: 3-6 years Education: Science Graduate Location: Hyderabad Skills: Regulatory Affairs, EU market, Formulation, RA, European market, Post and Pre approval

Regulatory Affairs CMC Experience: 6-11 years Education: Science Graduate Location: Hyderabad Skills: Regulatory Affairs, US market, CMC

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization an...

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry. Job Title: Director /VP (Regulatory Affairs) Location: Gurgaon Reports To: CEO About the Role We are seeking a highly skilled Regulatory Affairs Specialist to support global regulatory activities for our advanced Medical Devices/Equipments . This role plays a key part in developing regulatory strategies, managing submissions, and ensuring ongoing compliance for Class II and III medical devices. The successful candidate will have experience working with global health authorities, especially the US FDA , and a deep understanding of the regulatory landscape for complex medical tec...

Role & responsibilities Identify and evaluate relevant government tenders, EOI/RFPs, and bidding opportunities. Register and manage company profiles on government portals (e.g., CPP, eTendering sites). Prepare and submit bid documents in compliance with the requirements. Coordinate internally across teams to gather required documents, pricing, and technical inputs. Monitor the status of bids, follow up on clarifications, and track deadlines. Ensure full compliance with government norms, procurement policies, and legal documentation. Build and maintain strong relationships with government departments, PSUs, and other stakeholders. Maintain a database of submitted bids, awarded contracts, and ...

General Summary: The Technical Support Specialist II is responsible for assisting our partners in diagnosing and resolving a partners product issues or questions. This role works in partnership with cross-functional teams to troubleshoot, resolve, and document issues, getting partners back on track to having a positive experience with our products. Essential Duties & Responsibilities: Provides support to cross-functional teams, with a high attention to detail Researches, analyzes, and documents findings May influence others within the Technical Support team through the explanation of facts, policies, and practices Interacts with partners to provide technical support via email, phone, chat, c...

We help our customers free up time and space to become an Autonomous Digital Enterprise that conquers the opportunities ahead - and are relentless in the pursuit of innovation! Responsible for invoice processing in Oracle R12, Invoice are in multi-language and multi-currency. Supplier Reconciliation, analyzing invoices to identify duplicate invoices in day to day processing. Here is how, through this exciting role, you will contribute to BMC's and your own success: Invoice processing for different countries Ensuring that all the internal controls are met while processing the invoices Duplicate review before entering data into financials Preparing Weekly/Monthly reports as needed for AP Ensur...

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

Skills/Experience: GIT, Jenkins/Electric Commander/Hudson, Docker, Ansible, Python Domain: Devops Experience (years) : 2 to 10 years Location - Bengaluru,Hyderabad,Chennai,Pune

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

About Company BDO is a global professional services organisation and a leader in the mid-tier market, with a presence in over 166 countries and territories and a workforce of more than 119,611 people across 1800 offices. As part of this global network, BDO India offers a broad range of services, including Tax, Assurance, Accounting, Outsourcing, Advisory, and Technology-led solutions for both domestic and international clients across a variety of industries. Our commitment to innovation allows us to deliver high-quality, value-driven solutions that are adaptable to the rapidly changing business landscape. By staying ahead of industry trends, we ensure that our clients are equipped with the t...

Pharma & Life Sciences Recruiter ???? Full-Time | ???? Staffing & Recruiting About Us At Stelton Consulting , we are a trusted partner in Talent Acquisition & Workforce Solutions. Our mission is to connect top talent with leading pharmaceutical, biotech, and life sciences organizations across the U.S. We are expanding our team and looking for an experienced Pharma & Life Sciences Recruiter who thrives in a fast-paced environment and has a proven track record of finding and placing specialized talent in highly competitive markets. Key Responsibilities End-to-end recruitment for pharma and life science positions across multiple domains. Source, screen, and interview candidates for specialized ...

11:00 AM -8:00 PM/ 12:30 PM-9:30 PM (Sunday off) We are seeking a detail-oriented and proactive Cosmetic Regulatory Affairs Assistant to join our team. The successful candidate will support the Regulatory Affairs department in ensuring that our cosmetic products comply with all relevant regulations and standards. This role involves assisting with the preparation and submission of regulatory documents, maintaining regulatory databases, and staying updated on regulatory changes. Key Responsibility will be: Ensure compliance with all relevant regulatory standards and guidelines. Monitor changes in relevant legislation and the regulatory environment, taking appropriate action as needed. Assist i...

About The Role Job TitleAssociate Process Manager - SkillKYC Mumbai and Pune|Full-time (FT)|Financial Markets Shift Timings-APAC/EMEA/ NAM |Management Level- SA | Travel Requirements- NA Role & Responsibilities The ideal candidate must possess strong communication skills, with an ability to listen and comprehend information and share it with all the key stakeholders, highlighting opportunities for improvement and concerns, if any. He/she must be able to work collaboratively with teams to execute tasks within defined timeframes while maintaining high-quality standards and superior service levels. The ability to take proactive actions and willingness to take up responsibility beyond the assign...

Assistant Manager Product Regulatory Location: Gurugram (Hybrid minimum 3 days/week in office) Industry: Consumer Durables / Electronics Experience: 5+ Years Job Description: We are looking for a skilled professional with hands-on experience in BIS certification and Indian safety compliance . The ideal candidate will handle regulatory processes including BIS (CRS scheme) and WPC applications , coordinate with testing labs and overseas factories, and ensure timely product approvals in line with Indian regulations. Key Responsibilities: Manage end-to-end BIS certification and WPC applications Prepare and submit accurate documentation for regulatory approvals Ensure compliance with Indian safet...

Eisai Pharmaceuticals India Pvt. Ltd. is looking for Coating & Inspection Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the ...