454 Regulatory Submissions Jobs - Page 5

Role Overview: As a Regulatory Labelling Specialist at Apotex Inc., you will be responsible for performing all labelling update and maintenance activities related to New Product Development Label creation and Product Life Cycle maintenance for products in the Canadian market. Your role will involve interacting with the point of contact for allocated products, coordinating with vendors/affiliates for artwork creation and updates, and maintaining trackers for label submissions to health authorities. Key Responsibilities: - Coordinate and prepare regulatory submissions and strategies for labelling updates. - Prepare and submit supporting documents for labelling submissions in the Canadian marke...

Role Overview: You are an experienced Lead Statistical Programmer responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficac...

Role Overview: You will provide medical expertise for site identification, study feasibility, study design, conduct, analysis, and reporting. Your responsibilities will also include the generation of integrated databases, pooled analyses for efficacy and safety, ISE and ISSs, as well as dossiers for regulatory submissions for market authorizations of new medicinal products, diagnostics, and devices. Key Responsibilities: - Define regulatory strategies for submission of clinical trial applications, approval, and marketing trial applications in targeted regions such as India, U.S, and EU. - Prepare and review regulatory documents, dossiers containing technical, preclinical, and clinical data i...

Responsible for analytical method development, validation & transfer, ensuring cGMP & regulatory compliance. Supports R&D projects, stability studies, and dossier preparation for global submissions. Required Candidate profile M.Pharm or M.Sc with 10–15 years in AR&D for formulations. Hands-on with HPLC/GC, stability studies & regulatory documentation.

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your career. Here, your voice and ideas matter, your work makes an impact, and together, you will help us define the future of American Express. Key Responsibilites Regulatory Responsible for Regulatory Submissions like Quarterly RBI KRI submission. Responsible for Response to Regulatory Questionnaires/Circ...

Job description: PROFILE- Finance Manager (Need Candidates from Finance not from accounting) Job description: Experience - 8-15years Location- ITO, New Delhi JOB DESCRIPTION - Should be from banking or real estate sector. Conduct financial analysis, forecasting, and budgeting to support decision-making. Provide expert advice on investments, capital structure, cost control, and profitability improvement. Develop and implement financial strategies aligned with organizational or client goals. Identify and mitigate financial risks, ensuring compliance with tax laws, regulations, and reporting standards. Guide clients on business restructuring, mergers, acquisitions, or new projects. Prepare fina...

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser s local storage. This includes cookies necessary for the websites operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve websites performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Modify Cookie Preferences Accept All Cookies Find a Career With Purpose at Teva Search by Postal Code...

Role & responsibilities Preparation and reviewing of CTD and ACTD dossier. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. Co-ordination with plant for Regulatory compliances. Timely achievement of monthly plan & timely query response. Gap Analysis/Updation of Master data. Get feedback from all the countries for respective variation, and their timely submission. Renewals. Master data Updating. Follow ups with plant for documentation regularly and review meeting.

Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...

Enterprise & Treasury Risk Management / Capital Risk Management & recovery planning, AVP Position Overview In Scope of Position based Promotions (INTERNAL only) Job Title: Enterprise & Treasury Risk Management / Capital Risk Management & recovery planning, AVP Location: Mumbai, India Role Description Treasury Risk Management (TRM), within the Chief Risk Office function, provides a holistic oversight of financialrisks associated with Treasury activities. These include inter-related risks such as liquidity & funding risk, capital risk, structural interest rate and FX risks. Additional responsibilities include the submission of the ICAAP and the Group Recovery Plan, Resolution planning, 2LoD co...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Purpose: Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and p...

About Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the boundaries of science and technology. For the last 42 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ? 5% every year an achievement unrivalled by any company listed on the London Stock Exchange. Why join us ...

* Legal Manager* with 5+ years of *experience in real estate law* required for a *reputed real estate organization* located at *Andheri (W), Mumbai* *Candidates with a real estate background will be considered* JD: - *Advise management on legal, regulatory, and real estate matters* ensuring statutory compliance and risk mitigation - *Draft, review, and negotiate development, JV, sale, and vendor agreements* to protect company interests - Oversee RERA documentation, land title due diligence, property verification, and liaison with municipal bodies for approvals and clearances - *Represent the company before courts, authorities, and tribunals & manage legal notices, litigation, and regulatory ...

As an Authoring / writing and reviewing expert, your key responsibilities will include: - Authoring / writing and reviewing CMC sections of dossier - Critically reviewing design stage documents (specifications, controls, and protocols) to ensure regulatory requirements are met - Assessing change controls to determine regulatory impact and strategizing post-approval submissions - Coordinating the collection of post-execution data from various functions and reviewing for compliance with design specifications, controls, and protocols - Collaborating with cross-functional team members to ensure timely resolution of action items identified for responding to deficiencies - Reviewing and ensuring t...

Job description: PROFILE-Finance Manager (Need Candidates from Finance not from accounting) Job description: Experience- 8-15years Location- ITO, New Delhi JOB DESCRIPTION - Should be from banking or real estate sector. Conduct financial analysis, forecasting, and budgeting to support decision-making. Provide expert advice on investments, capital structure, cost control, and profitability improvement. Develop and implement financial strategies aligned with organizational or client goals. Identify and mitigate financial risks, ensuring compliance with tax laws, regulations, and reporting standards. Guide clients on business restructuring, mergers, acquisitions, or new projects. Prepare financ...

Job Title: Regulatory Affairs Head / Manager API Division Department: Regulatory Affairs Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API) Location: Andheri East Experience Required: 815 Years (API Regulatory Affairs) Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences) Salary Up to 1Lakhs per Month Job Purpose: To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies ...

Job Title: Regulatory Affairs Head / Manager API Division Department: Regulatory Affairs Industry: Pharmaceuticals Active Pharmaceutical Ingredients (API) Location: Andheri East Experience Required: 815 Years (API Regulatory Affairs) Qualification: M.Pharm / B.Pharm / M.Sc (Chemistry / Pharmaceutical Sciences) Salary Up to 1Lakhs per Month Job Purpose: To lead and manage the Regulatory Affairs department for API products, ensuring compliance with global regulatory requirements and facilitating product registrations, dossier submissions, and approvals across domestic and international markets. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies ...

As the clinical database and data management subject matter expert on Clinical Project Teams, your role involves the following key responsibilities: - Attend Clinical Project Team meetings to gather business need requirements and translate them into technical requirements - Partner with other shared service functions like Safety, Core Lab, etc. to gather business need requirements and translate them into technical requirements - Identify, analyze, propose solutions, and effectively resolve complex data issues by collaborating with the clinical project team members and other shared service functions - Train database End Users (internal and external users) on the database and/or maintain autom...

Role Overview: As the Assistant General Manager in Nasal Spray Formulation Development, you will be responsible for leading innovative projects from concept to commercial scale-up. Your focus will be on designing, developing, and optimizing nasal spray drug products, ensuring regulatory compliance and meeting quality standards. You will lead a team of formulation scientists and collaborate with cross-functional teams to deliver high-quality, cost-effective nasal spray formulations for global markets. Key Responsibilities: - Develop and technology transfer Nasal Sprays, Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for regulated markets like EU and US. - Prepare and review literatu...

Job Title: Executive / Senior Executive Regulatory Affairs (API) Location: Noida or Hyderabad, India Job Type: Full-Time Role Overview: We are seeking a motivated and detail-oriented Regulatory Affairs Professional to join our API regulatory team. The candidate will be responsible for preparing and reviewing eCTD sections of regulatory submissions (ASMF/CEP) and data packages for European markets, ensuring compliance with international regulatory standards. Key Responsibilities: Coordinate with cross-functional departments to arrange required technical data for ASMF/CEP and technical package preparation . Review quality and manufacturing data for APIs for regulatory adequacy as per relevant ...

- Develop & Execute regulatory strategies - Stay updated on evolving global regulatory requirements & ensure products comply with international standards - Collaboration with Cross functional teams including R&D, QA, Clinical developments. Required Candidate profile - Strong leadership & management skills, including experience leading cross functional teams - Proven track record of successful regulatory submissions & approvals

Job Description Job Responsibilities: International Registrations Upload, Verify, and Validate the data with new Regulatory Information to the RIM database Maintain Registration &Licensing Information Create Submission Packages for International Registrations Initiate Renewals with the countries. Initiate Product Change Notices per input from BU Project RA Specialist Establish and Maintenance of Dashboards on Product Change Notices Update PRAs (RIMSYS), NOR-D, and SAP system on regulatory status International and Local Labelling Initiate Local label Requests through Change Requests Monitor the status of the Label Change requests through Implementation Ensure timely completion of label releas...

This role will handle Legal Entity financial results including reviewing and analyzing information from the general ledger, month/year end book closure activities and timely entity level reports. The role will support in finalising financial information prior to submission to Group Finance, Business Partners and the Business Units. Job title: Analyst - Finance Job Description: Provide general accounting support and complete month-end activities. Review and analyze information from the general ledger and other accounting records to verify accuracy and completeness, taking corrective action as necessary. Process fixed assets for reporting and capital expenditure management. Capitalization and ...

Site Name: UK - London - New Oxford Street, Bengaluru Luxor North Tower, Egypt - Cairo, Poznan Grunwaldzka, USA - North Carolina - Durham, Warsaw Posted Date: Oct 27 2025 Are you a driven and innovative Regulatory Affairs professional looking to make a meaningful impact on the global supply of medicines Join our Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Group within Global Regulatory Affairs at GSK, where we play an essential role in ensuring uninterrupted access to life-changing medicines for patients worldwide. As part of the CMC Regulatory Affairs team, you'll collaborate across Global Supply Chain (GSC), Technical, Quality, and Local Operating Companies to support li...