3222 Regulatory Affairs Jobs - Page 45

Role & responsibilities Prepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017. Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24 etc.) for multiple products and clients. Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and approval processes. Track and manage multiple regulatory projects simultaneously, ensuring adherence to timelines. Maintain regulatory documentation, trackers, and compliance records for all client projects. Coordinate with SRSS internal teams and client stakeholders to collect required technical and compliance documentation. Monitor regu...

Responsible for the day-to-day activities of Regulatory Correspondence Department Co-ordinate with regulators. Maintain updates of action take regarding various correspondence Keep track of various circulars / notifications/ correspondence Required Candidate profile 7+ Exp in Capital Market Exp in coordinating & communicating with regulators Prepare reports / MIS Arranging & drafting minutes of the meetings

JOB DESCRIPTION: Job Profile -General Manager, India, Abbott Diabetes Care About Abbott: Abbott is a global healthcare leader dedicated to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 113,000 colleagues serving people in more than 160 countries, we are committed to making a lasting impact on global health. About Abbott Diabetes Care: Abbott Diabetes Care is a global leader in diabetes management, dedicated to helping people with diabetes lead healthier, happier lives. Our innovative product portfolio includes the FreeStyle family of glucose monitoring sys...

Job Title:- Assistant / Deputy Manager – Regulatory Affairs (US Market) We are hiring Regulatory Affairs professional for the US Market. The candidate will be responsible for preparing, reviewing, and submitting ANDA

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Role Overview: As a PV Physician at Dr. Reddy's Laboratories Ltd., you will be primarily responsible for overseeing and providing medical input for benefit-risk assessment activities. Your role will involve ad hoc data analysis, preparation and review of aggregate reports, signal detection and evaluation, support for benefit-risk evaluation efforts, and more. Your contribution will be crucial in ensuring the safety and efficacy of pharmaceutical products. Key Responsibilities: - Ensure quality control of medical assessment of individual case safety reports, including coding, seriousness, expectedness, and company causality assessments conducted by the vendor. - Contribute to scheduling of ag...

You are a dynamic regulatory professional with a strong Food Technology background, responsible for managing USFDA compliance and regulatory liaisoning for the food division of the International Business department. Your role includes handling product approvals, regulatory submissions, and documentation while serving as the primary point of contact with USFDA and related authorities. - Manage USFDA clearance, submissions, and compliance for food products. - Liaise with regulatory authorities, testing labs, and consultants. - Ensure compliance with USFDA labeling, safety, and regulatory norms. - Collaborate with R&D, QA, Manufacturing, and Business teams for product readiness. Qualifications ...

As a member of the Technical Operations team at Azurity Pharmaceuticals, you will play a crucial role in managing and overseeing technical process strategy, CMO and CDMO management, and the execution of product deliverables. Your dedication and expertise will contribute to the success of Azurity in providing innovative products to underserved patients. Here are the key responsibilities and qualifications required for this role: **Key Responsibilities:** - Manage the planning and execution of manufacturing for both development and commercial products, including qualification and validation activities. - Develop, review, and approve controlled documentation related to late-stage development, q...

This Job is based in Australia The Opportunity The Research Associate (Level A) will maintain and develop their scholarly research and professional activities through the pursuit of defined projects and contribute towards teaching and learning in the School, The Research Associate position is based at the UNSW Water Research Centre within the School of Civil and Environmental Engineering The role of the Research Associate reports to Professor Richard Stuetz and has nil direct reports, Salary, Level A $91,381 $121,838 per annum + 17% superannuation Full time Fixed-term contract for 3 years Location: Kensington Sydney, Australia About UNSW UNSW isnt like other places youve worked Yes, were a l...

prin.LN Welingkar Institute of Management Devlopment is looking for Senior Manager-Compliance & Legal Affairs to join our dynamic team and embark on a rewarding career journey Analysis for the current business practice Find out the different operational strategies Work on developing the current operational strategy applied to the company with the most recent technology Coordinate with the operations manager to take the required steps after brainstorming and research Optimize the operations in the company Put the suitable operational strategy to fit with the companys culture Implement the operational strategy in the different departments of the company Supervise the strategy, and make sure th...

Develop the regulatory compliance strategy / framework / compliance checklists for the various Centers of the company. Obtain all relevant licenses for Green field projects Verify all licenses of Brown field projects and support BD team in getting right licenses Read and interpret all the relevant acts and rules and prepare the procedures, forms, formats for obtaining regulatory clearances, licenses and permissions Keep track of all the changes in the various applicable laws, acts , rules and modify the existing processes, forms , procedures in alignment with the changes in the laws Work with Field / Geography teams for obtaining all the necessary regulatory permissions Develop relationships...

Greetings!!!! We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre. Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes. Key Responsibilities: Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved and Tentative) submissions. Responsible for filing supplements : CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates. Planning, reviewing, and timely submission of assigned projects in compliance with FDA guidelines . Strong interpretation of FDA queries and drafting of high-quality responses. Review and preparati...

The role involves preparing and reviewing regulatory documents, ensuring compliance with national and international guidelines, and supporting product registration processes. Required Candidate profile Looking for a Regulatory Affairs Officer with 2-3 years of experience in the Pharma/API sector. Candidates should have strong MS Office skills and good communication abilities.

Manage Off-site and Concurrent audits in line with internal and regulatory provisions. Ensure timely and high-quality deliverables to the Audit Committee of Executives and the Audit Committee of the Board. Lead and manage a team of approximately 40 members, ensuring effective utilization of manpower. Plan, design, and implement Off-site and Concurrent audits across business and support functions. Review departmental policies and SOPs, ensuring continuous alignment with best practices. Track and monitor open issues from audits, ensuring timely resolution. Devise audit checklists to strengthen audit effectiveness and coverage. Provide recommendations and suggestions to line management for impr...

Developing a deep expertise and understanding of Adobes Enterprise Term agreements (Digital Media Products) Conditions of Service & Commercial Terms. Researching customer contracts and purchasing history in Adobes various CRM systems in order to build timely and accurate quotations for Anniversary Payment within the portfolio Engaging with Adobe end users, distributors and resellers, secure Anniversary Purchase orders on time and support revenue growth through True-Up motion. Engaging with business partners in sales, finance, etc. to resolve issues raised by Customers or partners related to anniversary & True-Up payments Securing and validating Purchase orders on time, driving maximum recurr...

As a Consultant, you will be a key resource on client engagement. Be up to date with key technical and functional skills, and industry trends Skills and attributes for success Experience in Transfer Pricing and/or direct tax domain Skills and attributes To qualify for the role you must have Qualification Chartetred Accountant/ Postgraduate in Economics / MBA Finance Experience Prior experience/insight into Transfer Pricing Regulations (India and OECD) and/or India Income Tax provisions are desirable.

About The Role : Job TitleRegulatory Control Analyst Corporate TitleAssociate LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collecti...

About The Role : Job Title - Non Party Reference Data, NCT Location - Bangalore, India Role Description: The Senior Analyst will be responsible for completion of day-to-day activity for IRDS process. The primary function of the role is to work within Reference Data Space which includes Reference/static data setup and maintenance, Data quality queries/ issues received from client, Exception management, Reconciliation of data between systems, monitoring the data quality report and to ensure accurate, timely and quality delivery of services provided within a risk-free controlled environment, to ensure Deutsche Banks overall client satisfaction. Further daily/weekly/Monthly MIS, client escalatio...

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Pr...

About The Role : Job Title Bond Analytics Analyst LocationMumbai, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader incash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments ofcorporate and commercial clients and financial institutionsacross the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Securities Service (TSS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Securities Services team at D...

About The Role : Job TitleAFC & Compliance Third Party Risk Management Specialist, Associate LocationPune, India Role Description As part of DWS AFC & Compliance function, the global Anti-Fraud, Bribery & Corruption (AFBC) team is inter alia responsible for the design and execution of the Third Party Risk Management (TPRM) framework within DWS related to Risk Types owned by AFC & Compliance within DWS Group globally. Furthermore, the team advises and provides training to DWS global staff on these matters and interacts regularly with key stakeholders within DWS business and infrastructure functions. The AFC & Compliance Associate Third Party Risk Management Specialist reports to the Head of D...

About The Role : Job TitleRegulatory Control Analyst, NCT LocationBangalore, India Role Description The candidate for the AFC Centre of Excellence for KYC is supporting CB and IB KYC escalations to AFC, collaborating with the relevant Business stakeholders, Client Lifecycle Management and other AFC functions. Primary focus of the reviewer would be to ensure they review and approve the risk factor highlighted by CLM team as part of NCA/EDR/PRs Organization Deutsche Bank (DB) is committed to the highest standards of Anti-Money Laundering (AML), Sanctions & Embargoes, Anti-Bribery and Corruption (ABC) and Anti-Fraud & Investigations (AF&I) and wider Financial Crime (collectively referred to as ...

About The Role : Job TitleRegulatory Filtering Analyst, NCT LocationBangalore, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals...

About The Role : Job Title CSO Environmental and Social Due Diligence & Sustainable Finance Manager LocationMumbai, India Corporate TitleAS Role Description The Chief Sustainability Office is responsible for developing Deutsche Banks sustainability strategy and driving its implementation across all business divisions, infrastructure functions, and regions. Its core responsibilities include defining the strategic framework, coordinating the Banks sustainable finance activities, setting ESG standards, and overseeing regulatory and disclosure obligations. It comprises four teams: Strategy & Regional Governance , Execution, Data & Regulatory , Group Sustainability , and ESG Transparency . Strate...

About The Role : Job TitleRegulatory Filtering Analyst Corporate TitleAssociate LocationBangalore, India Role Description Deutsche Bank (DB) Group and its staff are committed to compliance with all applicable laws and official regulations in the respective jurisdictions. Restrictive measures under sanctions and embargoes are usually implemented by means of statutory regulations. The sanctions and embargoes program is aimed to ensure that DB Group and its staff fully comply with all sanctions and embargoes regulations in force in the respective jurisdiction. For this purpose, DB established a global organization with dedicated rights and responsibilities. DBs Sanctions & Embargoes Program has...