516 Regulatory Guidelines Jobs - Page 20

Role & responsibilities Position: Regulatory Associate CMC Location: Remote (India) Were looking for passionate professionals ready to grow their careers in a dynamic, global organization. Role Requirements: Masters degree in Pharmaceutical Sciences Minimum 2 years of experience in regulatory, quality, or document management support Hands-on experience with CMC (pre- and post-approval) Familiarity with Module 1 document preparation and country-specific administrative forms Skilled in maintaining regulatory trackers, submission timelines, and status reports Strong interpersonal and communication abilities Proficient in Microsoft Office (Word, Excel, PowerPoint) Be a part of meaningful work th...

Role & responsibilities : Lead Regulatory Affairs department. Should be well versed with submission of Document in CTD/ACTD Format for Regulatory & ROW Market. Should be able to handle team. Preferred candidate profile Reputed Pharma background.

Role & responsibilities: The candidates Core Profile would be Handling RBI Compliances, so 3-5 years RBI Experience is must. Required Experience: RBI Ensuring various Compliances under Master Direction of Reserve Bank of India for NBFCs and amended Rules thereon. Dealing with various circulars as issued by RBI i.e. Scale Based Regulations, Outsourcing Guidelines etc. Dealing with Fraud Guidelines and filing returns of fraud i.e. Monthly Certificate of Fraud, FMR-1, FMR-3 & FMR-4 (XBRL / CIMS Format) Taking prior approval from RBI for appointment of Directors & other matters Handling Select scope inspection from RBI and drafting of requisite replies for the inspection letter Working Knowledge...

Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.

Role & responsibilities The role of Wholesale Banking - Business Unit Compliance Officer (WB BUCO)” is to reinforce the compliance culture in Wholesale Banking and proactively addressing regulatory and operational risk minimizing losses and providing operational stability. It encompasses implementation of regulatory guidelines within all Wholesale Banking Business and Product units, viz. Large Corporates, Mid-Corporates, Financial Institutions, Government Institutions, Multinational Corporates, Transaction Banking, Project Finance, and Loan Syndication, working in close coordination with Central Compliance and Operational Risk Management units” Strengthens Compliance Culture - Reinforces the...

Role & responsibilities 1. Formulation & Development for emerging & regulated market. 2. Execution of Lab Trial batches & Tech Transfer activities at site. 3. Lab note book writing & documentation ensuring compliance with regulatory guidelines \ Preferred candidate profile - Experience in Tablets, Capsule, Pellets, ER, SR, and DR product development for emerging market.

This Opportunity is with a leading Banking company for their office in Mumbai location Role: MIS & Regulatory Submissions - TM Experience: 10 - 15 Years Job Description: PURPOSE OF THE JOB: - Will be responsible for reporting of Complaints Performance which includes Closure TAT, Pendency and Top Areas of Complaints, different MIS on complaints to senior management and all regulatory submissions. As a control function, will be responsible to identify non-compliance to Complaint Management processes of the bank, incorrect selection of CRM fields, and to ensure corrective action/ process improvement. Roles & Responsibilities: KEY RESPONSIBILITIES: 6 - 8 Areas Actionable (4-6) Regulatory Reporti...

Hands-on experience in designing, launching, & managing Prepaid Forex Card programs. shaping & executing our prepaid product strategy, ensuring seamless operations, regulatory compliance, and delivering value to our customers Required Candidate profile Understanding & internalising the cost and revenue aspects of the card program as given by Network partners. Negotiation with Program managers on various aspects of card launch

Job description -Candidate should possess experience in carrying out audit in Treasury function covering Derivatives, Forex dealing room. The activities to be covered as part of the audit would inter-alia cover the following aspects: Document verification of Forex and derivative transactions Term Sheet scrutiny along with detailed scenario analysis Review of entries related to forex and treasury operations on sample basis Settlement checks Voice Record checks Experience in handling concurrent audits / internal audits in the areas of Treasury function. Candidate should possess experience in carrying out audit in Treasury function covering Fixed Income Securities, Equities, Forex etc. Candidat...

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for com...

Knowledge of Process development for APIs and intermediates/Trouble shooting of products at plant level/Planning and executing the experiments/Technology transfer to plant level/Handling reactions from mg to gram scale/ API R&D Required Candidate profile Cost reduction and plant troubleshooting/OD at plant site for technology transfer as & when required/ Chemistry/Regulatory Guidelines/GMP/GLP/ Timely delivery/ Compound interpretation NMR/LCMS/HPLC

Company Name: Oneiro Lifecare Pvt Ltd Designation: Regulatory Affairs - Sr Officer/Executive - API Location- Ekalbara Plant (Vadodara) Preferred candidate profile Experience: 3 to 5 Years (M.Pharm (Pharmaceutical Chemistry)/ M.Sc. (Chemistry)/ B.Pharm) JOB PROFILE Interdepartmental Coordination: Liaise with cross-functional teams (R&D, QC, QA, Manufacturing, etc.) to gather, review, and consolidate technical information required for regulatory submissions. API Chemistry & Characterization: Provide expert input on molecular chemistry , including impurity profiling , characterization , and Nitrosamine impurity assessment . DMF (Drug Master File) Management: Prepare, maintain, and update DMFs (...

Ensure compliance with corporate laws, including Companies Act, SEBI regulations, and FEMA guidelines. Organize board and committee meetings, including scheduling maintain statutory records and filings with regulatory bodies such as MCA, SEBI, RBI

Role & responsibilities: Conduct IS audits across technology domains; ITGC Controls, Risk Assessment, VA/PT, Application Security, NSAR, CA Assist in implementing a risk-based audit plan aligned with the organisation's audit objectives. Ensure timely completion of audit assignments and maintain clear, accurate documentation. Provide insights and recommendations to enhance internal systems, controls and policies. Update and maintain Audit Procedure Manuals and audit checklists. Collaborate with cross-functional teams to ensure regulatory and compliance alignment. Follow departmental risk policies and protocols to mitigate operational, financial, regulatory and reputational risks. Execute inte...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products

Job title: Principal Data Management Programmer Location: Hyderabad, India About The Job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do Join our Hyderabad Hub, build a career and you can be part of transforming our business while helping to change millions of lives ReadyAs Principal Data Management Programmer within our Hyderabad Hub, youll be responsible for developing program for data validation, data review and protocol deviation deliverables for assigned projects, providing timely support to Study Team(s) on data management programming or data visualization analytics according to ...

work: Expert in regulatory compliance Oversee RBI reporting, guidelines adherence & risk management Manage government affairs, liaison & relations FEMA expertise Escrow & Consortium Knowledge Biz Development & Management Communication skills Annual bonus Health insurance

Role & responsibilities Should be well conversant with IRAC, Exposure, Large exposure norms, Resolution Plan Implementation, Sensitive sector monitoring, etc. Exposure in preparation of DSB, CRILC, PSL, MSME, SLBC, Defaulter, NPA, Bureau reporting (CIBIL), NeSL submission, Quarterly disclosure preparation, Risk Based Supervision submission, Potential NPA tracking, Exception reports, SCOD tracking, etc. Facilitate Half yearly review of all process notes and QC checklists to align with extant circulars. Excellent oral and written communication. Excellent project management skills to manage multiple automation projects with circular implementations. To be able to provide assistance in evaluatio...

About The Role : In Scope of Position based Promotions (INTERNAL only) Job Title Model Validation Specialist Associate Location Mumbai, India Role Description Model Risk Managements mission is to manage, independently and actively, model risk globally in line with the bank's risk appetite with responsibility for: Performing robust independent model validation; Ensuring early and proactive identification of Model Risks; Effectively managing and mitigating Model Risks; Establishing Model Risk metrics; Designing and implementing a strong Model Risk Management and governance framework; Supporting bank-wide Model Risk-related policies. This role spans all aspects of validation applicable to the p...

About The Role : Job TitleClient Implementation Analyst, NCT LocationPune, India Role Description In accordance with Anti-Money Laundering Requirements, Banks are obliged to perform Know-your-client (KYC) reviews on all new clients they adopt. These checks and reviews are made in strict accordance with regulatory requirement and the banks internal policies. The project involves verification of the Client data, performing due diligence checks on the Clients, reviewing KYC documentation performing the risk assessment of the Client, liaising with the Business/Compliance, advising on KYC requirements and signing off on new client adoptions. What we'll offer you As part of our flexible scheme, he...

Role & responsibilities Safety Officer to oversee and enforce safety protocols in our pharmaceutical manufacturing environment. The ideal candidate will ensure compliance with occupational health, safety, and environmental standards, contributing to a safe workplace and sustainable operations. This position requires strong working knowledge of pharmaceutical industry safety norms, including GMP and regulatory guidelines. Implement, monitor, and continuously improve safety systems in compliance with GMP , GSP , and regulatory guidelines (USFDA, MHRA, WHO, etc.). Conduct safety audits, risk assessments, and inspections within manufacturing, laboratory, and utility areas. Develop, implement, an...

Roles and Responsibilities Prepare dossiers, variations, renewals, and amendments for regulatory submissions to FDA and other global health authorities. Coordinate with cross-functional teams to ensure timely submission of regulatory documents. Maintain accurate records of all regulatory correspondence, reports, and audit findings. Ensure compliance with regulatory guidelines and requirements by reviewing documentation and conducting internal audits. Provide support during regulatory audits by gathering necessary information and preparing responses. Desired Candidate Profile 1-4 years of experience in Regulatory Affairs or related field (pharmaceutical industry). Bachelor's degree in Pharmac...

Job Responsibilities: Perform pre-formulation studies, R&D trials and support scale-up activities. Conduct R&D trials for oral solid dosage forms (tablets, capsules, etc.). Develop and optimize formulations to meet regulatory and quality requirements. Document and analyze trial data to improve formulations. Collaborate with cross-functional teams for technology transfer to manufacturing. Requirements: M.Pharm or equivalent in Pharmaceutics/Pharmaceutical Sciences. Hands-on experience in formulation development of oral solid dosage forms. Knowledge of QbD, regulatory guidelines, and process optimization. Strong analytical and problem-solving skills.

Basic Section No. Of Position 1 Grade ST Level Staff Organisational BUSINESS Metals BUSINESS_UNIT-1 Aluminium BUSINESS_UNIT-2 Chemicals Marketing BUSINESS_UNIT-3 Chemicals Muri DEPARTMENT-1 Integrated Health Services Country India State Jharkhand Worksite Muri, Ranchi Industry Manufacturing Function Health, Safety and Environment Skills Skill Occupational Health Nursing Treatment Planning Waste Management Clinical Pharmacy Emergency Management Billing Process Activity Coordination Team Building Interpersonal Abilities Safety WCM-Interwoven MIS & Analytics Minimum Qualification Bachelor of Nursing Degree Diploma in Nursing CERTIFICATION No data available About The Role About The Role Support ...

Role & responsibilities Managing Audit Committee of the Board (ACB) /Audit Committee of Executives (ACE) related activities Ability to handle pressure and meet meeting deadlines Ensuring compliance with Internal and regulatory guidelines Prepare presentations for Audit Committee Meetings Preparation and submission of error free minutes of the Committee within the prescribed time Comprehensiveness of the deliberations of Audit Committee meetings captured Accuracy of the ATRs based on the Audit Committee deliberations Timely preparation of Action Taken Report Ensuring directives / suggestions of ACB/ACE/Management are circulated within the organization /Department. Tracking directives / sugges...