114 Regulatory Documentation Jobs - Page 4

Key Deliverables: Prepare regulatory documents ensuring anonymization and redaction compliance Develop and maintain written redaction strategies for studies/products Coordinate with cross-functional teams for review and timely submission Support trend analysis and clinical disclosure process improvement Role Responsibilities: Interpret and apply clinical data within regulatory frameworks Follow SOPs and controlled processes for document preparation Manage timelines and priorities to meet disclosure deadlines Communicate and escalate document or strategy issues as needed

The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating Procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help exe...

The Know Your Client (KYC) Analyst focuses on client onboarding (COB) and exceptions in line with regulatory standards and jurisdictions. The KYC Analyst provides regular communication to senior bank stakeholders on changes in KYC, Anti Money Laundering (AML) and Anti Financial Crime (AFC) areas and ensures any changes required are implemented with minimum disruptions. The KYC Analyst also assists the bank's clients, managing all KYC and account opening requirements with appropriate governance and controls. They operate in an environment of strict adherence to Standard Operating Procedures (SOPs) and Operation Level Agreements (OLAs) to achieve accurate and timely account opening to help exe...

Seeking candidate with hands-on experience in compiling/reviewing ACTD & CTD dossiers, regulatory documentation, and timely submissions. Must coordinate with teams, follow regional guidelines, and manage multiple projects efficiently.

Roles and Responsibilities Responsible for preparation & compilation of the dossiers in CTD/eCTD/ACTD and other formats as required for submission to different regulatory authorities. Review the documents i.e. Specifications, Batch Records, STP, Stability Protocol, Dissolution protocols & DMF documents etc. Preparation of pharmaceutical/quality part (all forms) of registration dossiers & variations/amendments/annual reports as applicable documents in CTD and eCTD format. Preparation of query response for submitted applications received from various regulatory authorities. Responsible for review of change controls and checking for regulatory compliance for all documents. Exposure of Dossier c...

Roles & Responsibilities: 1. Product Registration: Handle the registration of products under FDCA (Food and Drugs Control Administration) for necessary approvals. 2. Label Claim Verification: Coordinate with the Formulation & Development team to confirm and validate claims mentioned on product labels and the regulatory classification of each product. 3. Artwork Coordination: Work closely with the sales team to ensure that product artworks (for existing and new products) meet all relevant regulatory requirements. 4. Renewals & Compliance: Manage the timely renewal of product approvals under applicable regulatory bodies, maintaining full compliance throughout the product lifecycle. Qualificati...

We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously.

Ensure documentation of Forest Clearance application & Wildlife Clearance application with consultant Ensure verification of DGPS & Toposheet maps required under application Ensure compliance with forest and wildlife regulatory frameworks throughout the clearance process. Assist in preparing reports and updates for project stakeholders and regulatory bodies.

We are looking for a meticulous Executive/Sr. Executive to spearhead regulatory submissions and review at Synnat Pharma Private Limited. In this pivotal role, you will be instrumental in ensuring our API manufacturing processes adhere to global pharmaceutical regulations. Your expertise will be essential in compiling, reviewing, and submitting comprehensive regulatory documentation to various health authorities, including the US FDA, EMA, and CDSCO. You will manage regulatory inspections, handle queries, and lead the preparation of DMF filings. The ideal candidate will possess a deep understanding of regulatory guidelines, ICH guidelines, and relevant pharmacopeias (USP, EP, BP), coupled wit...

Role Description Operations provides support for all of Deutsche Banks businesses to enable them to deliver transactions and processes to clients. Our people work in established global financial centers such as London, New York, Frankfurt and Singapore, as well as specialist development and service centers in locations including Bucharest, Moscow, Pune, Dublin and Cary. We process payments in excess of a trillion euros across the banks platforms, support thousands of trading desks and enable millions of banking transactions, share trades and emails every day A dynamic and diverse division, our objective is to make sure that all our services are executed in a timely and professional manner, t...

Roles & Responsibilities Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation Assist the Team Lead/Manager in the development of schedules to ensure timely delivery Manage timelines and communicate with team members to maintain awareness of expectations, m...

Key Responsibilities: Develop and validate analytical methods using HPLC, UV, IR, and GC. Prepare protocols and reports for method development and validation. Perform stability studies and sample analysis for new products. Maintain instruments and lab notebooks as per SOPs and GMP guidelines. Coordinate with formulation development and QA teams. Requirements: M.Sc. / B.Pharm / M.Pharm in Chemistry/Pharmaceutical Sciences. Knowledge of ICH guidelines and regulatory documentation. Hands-on experience with chromatographic techniques and software. Analytical Method Development of Assay, Related Substances, Residual Solvents & Dissolution Test Methods with Literature Search & Report.

R&D Executive (Food Technologist) with 3+ yrs experience in NPD, formulation, and tech transfer for nutraceuticals. Expertise in FSSAI compliance, ingredient selection, and product development. Location: Mohali. B. Tech in Food Tech required.

Serve as the Subject Matter Expert (SME) for counterparty onboarding, refresh processes across various markets and asset classes. Collaborate with broker-dealer counterparties Liaise with internal stakeholders Required Candidate profile Track onboarding milestones to ensure timely submission execution of onboarding steps. Maintain relationships with both external brokers internal business units. Leverage an in-depth understanding Perks and benefits Perks and Benefits

Title We are currently seeking an full time office based Experienced Study Start up Submissions Coordinator to join our Clinical Operations team in India Mumbai. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and ...

Title We are currently seeking a full-time, office-based Study Start up Submissions Coordinator to join our Clinical Operations team in Mumbai, India office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company’s success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our ...

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 Media section prepares small and bulk volume of media to produce FMD/HS antigens and related to cell and virus/ Bacterial culture sections To update the regulatory documents online Involved in microbial upstream and primary downstream processes Coordinating with internal and external departments like QC, QA, and engineering. Coordinate with cross functional department and participate in preventive and breakdown maintenance of equipment and machines Preferred candidate profile Should have experience in handling various bioreactors adherent and suspension cell cultures, cell passaging. Exposure to regulatory audits.

Prepare, submit regulatory dossiers for new product registrations Coordinate and manage the submission of regulatory documents Facilitate communication with health authorities, responding to queries Required Candidate profile M. Pharm (Female Candidate Preferred) 1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired. Excellent communication skills.

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...

Roles & Responsibilities Author regulatory submission documents such as: Clinical Study Reports Investigator Brochures Responses to Questions Protocols and Protocol Amendments Informed Consent Forms Table of All Studies Clinical Overview Addenda eCTD Module 2 Clinical Summary Documents Briefing Documents Pediatric Investigation Plans Other regulatory documents as assigned Conduct formal review and approval of authored documents, adhering to SOPs Manage regulatory writing activities for product submissions under supervision, including new and supplemental drug applications/biologics license applications Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Gen...

Key Responsibilities: Manage the overall Quality assurance and Quality Check of products Responsible to ensure that that all products meet the highest standards of quality, safety, and regulatory compliance for a new Trade Generics business Work closely with the senior advisor & procurement manager for QA/QC of contract manufacturers & final products Initially report to promoter and later to Ops & Supply Chain Head Experience 5+ years of experience as a quality manager/ executive in the pharmaceutical industry, with strong knowledge of regulatory standards is must. Relevant roles: Quality Manage/ Quality executive of a pharmaceutical company Experience with leading the audit/ inspection/ reg...

Manage EMA registrations, liaise with authorities (EMA, BfArM, PEI), handle PI submissions, packaging, approvals. Review SmPC, PILs, labels, texts. Support RA team and associates, assist with data entry, invoicing, presales, and ensure EU compliance.

Spica Labs Pvt. Ltd. is hiring QC & QA male candidates with experience in HPLC, UV, IR, GMP, BMR review, SOPs, validation, deviations & regulatory knowledge. Send resumes to: spicalabspvtltd@gmail.com.

We are looking for a meticulous Assistant Manager R&D to spearhead API development initiatives at Glochem Industries. As Assistant Manager, you will play a crucial role in executing complex organic syntheses, optimizing reaction conditions, and assisting in the development of scalable and environmentally friendly synthetic routes for API manufacturing. Your responsibilities will span from meticulous documentation of experimental procedures and results to collaborating with cross-functional teams, including analytical, kilo lab, and pilot plant teams, for sample analysis and process scale-up. The ideal candidate will have a strong foundation in organic chemistry, a deep understanding of API m...