225 Regulatory Documentation Jobs

We are looking for a Qualified Company Secretary (CS) candidate (0- 2 years) to support the Compliance & Regulatory function within Forex Operations. The role involves working on RBI, FEMA, AML/KYC compliance processes, regulatory documentation, reporting, and coordination across operational teams. You will work closely with senior members and gain guided exposure to regulatory submissions, audit requirements, and compliance monitoring activities. Key Responsibilities: Assist in ensuring adherence to RBI, FEMA, KYC/AML guidelines. Help prepare basic compliance documents, reports, and regulatory submissions. Maintain updated records of circulars, notices, and internal compliance checklists. C...

As a part of the QC Department at Global Calcium Pvt. Ltd., a leading pharmaceutical manufacturer, you will have the opportunity to contribute to quality and innovation. We are currently hiring for multiple roles, including QC ICP-MS Analyst, QC DMF Support, QC Analytical Validation Support, and QC Wet Analysis. Join us in our commitment to excellence and be a part of a dynamic and growing team. Key Responsibilities: - Conduct routine and non-routine analyses using analytical techniques and instrumentation. - Develop and validate analytical methods and protocols. - Prepare and maintain detailed documentation and reports. - Ensure compliance with regulatory guidelines and GMP standards. - Col...

Role & responsibilities: To support and manage regulatory submissions, product registrations, and lifecycle maintenance activities in compliance with global regulatory requirements, ensuring timely approvals and sustained market authorization of pharmaceutical and life science products. Key Responsibilities Prepare, review, and submit regulatory dossiers (CTD / eCTD) for regulated and semi-regulated markets Handle product registrations, renewals, variations, and amendments Compile and maintain CTD Modules 15 as per regulatory guidelines Respond to regulatory authority queries, deficiency letters, and commitments within defined timelines Coordinate with QA, QC, R&D, Production, Packaging, and...

Role Overview: You will be the Controlled Documentation Lead in the R&D Quality department at Amgen. Your main responsibility will be to manage and maintain end-to-end lifecycle management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. You will work closely with stakeholders to coordinate document workflows, perform quality control checks, and ensure timely completion of documentation deliverables within the electronic document management system. Key Responsibilities: - Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards. - Track documentation milestones and follow up ...

As a Regulatory and Quality Manager at our company in Noida, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining high product quality standards. Your responsibilities will include: - Implementing the Quality Management System in accordance with regulatory guidelines. - Managing regulatory documentation to ensure accuracy and completeness. - Overseeing the Continual Improvement of Systems and Product Quality Review Process for the Corrective and Preventive Action System. - Ensuring data integrity and implementing Standard Operating Procedures (SOP) and policies. - Evaluating and approving master documents across various departments. - Preparing and...

The Candidate will be responsible to the Business Operations for Global as well as Developing New Business Opportunity by focusing on building and growing strong relationship both internally and externally. Devising effective Business Development Strategy for future research-based products with global Clients in Nutraceutical, Dietary & Natural/ Herbal Supplements for all categories. KEY DELIVERABLES: Strategic and Operational Excellence Identifying opportunities to build, develop and strengthen relationships with global clients to grow and sustain the business by strategizing optimum customer selection and management, team expansion and nurturing a healthy cross functional team culture. Ide...

About Us: https://www.clyzo.com/aboutus An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform CLYZO Position- Regulatory Affairs Associate. Job Description : An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having experience and knowledge of handling technical queries and regulatory documentation. Responsibilities: Handling entire regulatory documents of excipients. Resolving technical queries of big pharmaceutical clients Handling technical matters & document related work of excipient manufacturer. Preparation of in h...

Prepare, review, and maintain regulatory documentation. Prepare dossiers. Assist in filing applications, registrations, renewals. Freshers & experienced can also apply.

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Job Description/ Capsule Collates information, communicates, and prepares responses for Health Authority queries to facilitate regulatory processes. Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation. Supports the development of India-specific artwork, ensuring compliance with regulatory requirements. Supports the preparation and submissio...

As a Junior Doctor Medical Operations & Project Coordinator for the BluHealth Project, your role will involve a combination of health screening, medical project planning, field coordination, and clinical screening supervision. You will be responsible for supporting operational execution, study coordination, documentation, and data management activities while also actively participating in health screening initiatives. **Key Responsibilities:** - Conduct and supervise health screening sessions using BluHealth's applications and portable scanner devices. - Review and validate patient vitals captured through devices, ensuring clinical accuracy. - Use your domain knowledge of health biomarkers a...

Company Description Triethix Clinical Research is a clinician-led Site Management Organization (SMO) based in Ahmedabad, India, specializing in efficient and compliant execution of clinical trials. Focused on optimizing trial site operations, Triethix collaborates with CROs, sponsors, and investigators to deliver expertise in site feasibility, startup strategy, regulatory coordination, patient recruitment, and protocol adherence. With leadership from a pulmonologist and medical director, the organization ensures real-world clinical relevance in its research studies. Triethix is committed to advancing clinical research partnerships and multi-site trials with a patient-centric approach. Role D...

About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Job Description/ Capsule Collates information, communicates, and prepares responses for Health Authority queries to facilitate regulatory processes. Maintains and updates submission trackers to ensure accurate and up-to-date regulatory documentation. Supports the development of India-specific artwork, ensuring compliance with regulatory requirements. Supports the preparation and submissio...

Company Description HRV Pharma is a global leader in manufacturing Active Pharmaceutical Ingredients, Intermediates, and Formulations. Headquartered in India, the company serves clients worldwide with offices in the USA, Dubai, Lithuania & Switzerland, and Turkey. HRV Pharma is known for its commitment to quality and its ability to meet diverse customer needs seamlessly. It continues to expand its footprint in the pharmaceutical industry through innovation and excellence. Responsibilities Drive new API business across international markets Build, qualify & convert high-quality leads Manage the complete sales cycle: prospecting ? presentations ? quotations ? negotiations ? closures Strengthen...

Position - Scientific Associate Director - Pharmacokinetics and Drug Metabolism (Small Molecule ADME Lab Lead) In this vital and exciting role, you will oversee Pharmacokinetics and Drug Metabolism (PKDM) activities at our upcoming research facility in India. This role involves interaction with various Amgen scientists supporting small molecule (SM) programs. You will also co-ordinate with local CROs involved in characterizing the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK) properties of SM therapeutic drug candidates. In this role, your core responsibilities include: Lead/mentor a team of scientists involved in ADME characterization of small molecules Dir...

As a Regulatory Affairs Executive (Packaging & Labeling) at Meghmani Lifesciences Ltd, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining regulatory documentation. Your responsibilities will include: - Preparing and maintaining regulatory documentation - Coordinating with various departments to gather necessary information - Reviewing and ensuring that packaging and labeling meet regulatory standards - Acting as a bridge between Vendors, Studio/Design Team, Marketing, QA, and Supply Chain - Ensuring timely finalization of artwork & packaging materials - Coordinating on label claims & regulatory compliance - Overseeing the printing & packing for F...

You are seeking a highly skilled Electronics Engineer capable of developing standalone electronic systems from concept to production. Your expertise should include digital and analog circuit design, component selection, PCB design, and system-level simulation. Experience with medical electronics, compliance standards (IEC 60601, ISO 13485), and EMI/EMC-compatible design practices is essential. - Lead the end-to-end design and development of electronic systems for standalone and embedded medical devices. - Design and simulate digital, analog, and mixed-signal circuits using tools such as LTSpice, Multisim, or Proteus. - Perform signal integrity, power integrity, and thermal simulations during...

Requisition Id: 1664549 As a global leader in assurance, tax, transaction and advisory services, we hire and develop the most passionate people in their field to help build a better working world. This starts with a culture that believes in giving you the training, opportunities and creative freedom. At EY, we don't just focus on who you are now, but who you can become. We believe that it's your career and It's yours to build which means potential here is limitless and we'll provide you with motivating and fulfilling experiences throughout your career to help you on the path to becoming your best professional self. The opportunity : Associate Analyst-National-TAX-TAX - ITTS - Corporate Tax A...

As a global leader in manufacturing Active Pharmaceutical Ingredients, Intermediates, and Formulations, HRV Pharma is committed to quality and meeting diverse customer needs across international markets. You will drive new API business, build high-quality leads, manage the complete sales cycle, and strengthen relationships with existing clients. Additionally, you will track market trends, represent the company at pharma exhibitions, and ensure regulatory compliance throughout the sales process. Key Responsibilities: - Drive new API business across international markets - Build, qualify & convert high-quality leads - Manage the complete sales cycle: prospecting, presentations, quotations, neg...

As a Pharma API Sales Professional with 3-5 years of experience, you will be responsible for driving new API business across international markets. Your key responsibilities will include: - Building, qualifying, and converting high-quality leads - Managing the complete sales cycle, from prospecting to presentations, quotations, negotiations, and closures - Strengthening relationships with existing clients to ensure repeat business - Tracking market trends, competition insights, and preparing sales/MIS reports - Representing the company at major pharma exhibitions, trade fairs, and client visits - Ensuring regulatory compliance throughout the sales process, including DMF, CoA, stability data,...

Roles and Responsibilities Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission...

Company Description Graviti Pharmaceuticals, established in Hyderabad, India, is a research-driven company specializing in the production of high-quality and complex generic formulations. The organization focuses on developing modified-release formulations, bio, stability-sensitive molecules, and innovative drug delivery platforms. Known for its excellence in manufacturing, Graviti Pharmaceuticals adheres to and exceeds regulatory standards, ensuring superior-quality products. Our values of reliability, integrity, and transparency form the foundation of enduring partnerships and trust. Role Description This is a full-time, on-site role located in Hyderabad for a Regulatory Affairs Profession...

Prepare & review dossiers Manage product registrations/submissions Ensure regulatory & documentation compliance Coordinate with QA/QC/R&D teams Review artworks/labels Support audits & authority queries Call on- 9662266641/9662266691

Title: Regulatory Officer We are seeking a detail-oriented Regulatory Officer with hands-on experience in handling export regulations for pharmaceutical products across African and Middle Eastern markets. The ideal candidate will have a science background and be well-versed in regional regulatory frameworks, dossier preparation, and registration processes. Key Responsibilities: Prepare, review, and submit registration dossiers as per country-specific guidelines. Ensure compliance with regulatory requirements for product exports to Africa and the Middle East. Liaise with local authorities, distributors, and regulatory consultants. Monitor changes in regulatory policies and update internal tea...

As an Electronics Engineer at our company, you will play a crucial role in developing standalone electronic systems from concept to production. Your expertise in digital and analog circuit design, component selection, PCB design, and system-level simulation will be essential. Experience with medical electronics, compliance standards (IEC 60601, ISO 13485), and EMI/EMC-compatible design practices is a must. Key Responsibilities: - Lead the end-to-end design and development of electronic systems for standalone and embedded medical devices. - Design and simulate digital, analog, and mixed-signal circuits using tools such as LTSpice, Multisim, or Proteus. - Perform signal integrity, power integr...

You will be responsible for managing export documentation including LC, BL, COO, Phyto, Invoice, Packing List, etc. You will be required to coordinate with CHA, shipping lines, and freight forwarders to ensure smooth shipment execution. Additionally, you will handle export order processing, negotiation, and dispatch planning. It will be your responsibility to maintain communication with international clients for order updates and query resolution. You will also be supporting export compliance, customs clearance, and regulatory documentation. Furthermore, you will prepare MIS reports related to export activities. The company deals with Export Sales of Basmati and Non-Basmati rice. Qualificati...