170 Regulatory Documentation Jobs - Page 4

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.

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and document...

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client c...

DEPARTMENT: Corporate Solutions As a member of the COSEC Team you will be expected to work in collaboration with other members of the Team, assist and support in providing administrative, compliance and regulatory services of to overseas client Companies, in accordance with applicable policies and procedures, regulatory requirements, service levels and company standards so as to satisfactorily meet client expectations. The Role: Understanding corporate and legal compliances as per jurisdiction in which client companies are located. Handling compliances and documentation under the applicable anti-money laundering regulations. Handling compliance relating to Board Meetings of overseas client c...

About The Role : We are seeking a detail-oriented and experienced Biostatistician II to support statistical analyses for clinical research studies. This role involves developing and validating SAS programs, preparing statistical documentation, and ensuring compliance with regulatory standards such as CDISC. The ideal candidate will have a strong foundation in statistics, clinical trial methodology, and statistical programming. Key Responsibilities: Develop, validate, and maintain SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans. Design and verify randomization codes to ensure clinical trial integrity. Prepare statistical secti...

#hiring for a Leadership role in #RegulatoryAffairs with reputed organization into Hi-end Medical Devices industry. Job Title: Director /VP (Regulatory Affairs) Location: Gurgaon Reports To: CEO About the Role We are seeking a highly skilled Regulatory Affairs Specialist to support global regulatory activities for our advanced Medical Devices/Equipments . This role plays a key part in developing regulatory strategies, managing submissions, and ensuring ongoing compliance for Class II and III medical devices. The successful candidate will have experience working with global health authorities, especially the US FDA , and a deep understanding of the regulatory landscape for complex medical tec...

Immediate requirement for Executive - Regulatory function for one of the leading pharma company Position : Executive ( Regulatory function ) Educational qualification: MSc/MPharm Experience : 3 to 6 years of relevant experience. CTC : up to 6 LPA Contract Period: 1 Year (It can be extended based on performance ) Work Location : Thane office (Maharashtra) Transport provided : Yes (from Thane station) Working Mode ( Remote / Hybrid ) : Work from office. Shift timings : 9 am to 5.30pm Main Responsibilities: KEY RESPONSIBILITIES 1) To maintain high degree of quality of documents required for submissions to get the approval without deficiency / non-critical deficiency. 2) Timely readiness and sub...

Formulation Experience Mandatory: Well aware of EU, Australia, Ukraine & UK market requirement Dossier Preparation in ACTD & CTD Format ICH guidelines Communication skills Documents Management Stakeholder Communication

We are hiring for Biomedical Engineer skills :- product development & Engineering , Regulatory documentation (CDSCO , BIS etc.) , Quality & Compliance , Manufacturing support , Customer & hospitality Interaction Experience :- 3-5 yrs Salary :- 25-30k Interested candidate share your cv at 7042494894 or 7042740655/56

We are seeking an Associate RA (Regulatory Affairs) professional to assist with the preparation and submission of crucial regulatory documents. This role primarily focuses on Module 1 documents and various lifecycle maintenance activities, ensuring compliance with global regulations. The ideal candidate will have a master's degree in pharmaceutical sciences and experience in a regulatory support role, demonstrating excellent communication and organizational skills. Essential Functions Regulatory Document Preparation: Assist with the preparation of Module 1 documents and the collection of country-specific administrative forms. Aid in preparing various regulatory submission documents , includi...

The Regulatory and Quality Manager role in Noida requires a female candidate and involves various responsibilities related to quality management and regulatory compliance. You will be responsible for implementing the Quality Management System in alignment with regulatory requirements. This includes managing regulatory documentation and overseeing the Continual Improvement of Systems, Product Quality Review Process, Corrective and Preventive Action System. Your accountability extends to ensuring data integrity and implementing SOPs and policies. You will evaluate and approve master documents across different departments and prepare and approve various master documents such as BMR, SOP, STP, S...

As a Product Compliance & Quality Specialist in the Hygiene & Personal Care industry, you will be responsible for leading compliance, product claims, and quality systems for impactful categories including Handwash, Sanitizers, Toilet Cleaners, Detergents, Baby Products, Cosmetics, AYUSH, Medical Devices, and Wellness Products. Your role will involve ensuring compliance with regulatory bodies such as BIS, LM, CDSCO, AYUSH, and EPR rules. You will define test protocols, verify claims, drive audits, manage product documentation, artwork, risk assessments, and CAPA processes. Collaboration with cross-functional teams including R&D, Legal, Marketing, and Vendors will be key to success in this rol...

You will be responsible for liaising with banks, external auditors, the Federal Tax Authority (FTA), and internal departments to ensure financial compliance and reporting. This includes overseeing the proper and timely filing of UAE VAT returns and coordinating GST compliance with the India finance team. You will provide regular financial reports to management, including P&L, balance sheet, AR aging, and cash flow statements. Additionally, you will lead the monthly and annual financial closing process to ensure accuracy and compliance with IFRS and local laws. Monitoring project-based revenues and expenses will be a key aspect of your role, ensuring accurate cost allocation and profitability...

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma. Job Summary Collation, compilation and dispatch/submission of regulatory documentation for assigned projects. Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures. Supporting and/or coordinating regula...

As a Regulatory Compliance Specialist, your primary responsibility will be to ensure that company products adhere to relevant regulatory requirements, including those stipulated by USFDA, FDA, EMA, and local regulatory bodies. You will be tasked with preparing and submitting regulatory documents such as INDs, NDAs, and MAAs to regulatory agencies. Additionally, you will play a pivotal role in developing and executing regulatory strategies that support product development and commercialization efforts. Your role will also involve staying abreast of evolving regulatory standards and providing guidance to internal stakeholders based on regulatory intelligence. You will coordinate and oversee re...

The Senior Associate Regulatory Project & Resource Management plays a crucial role in supporting and streamlining regulatory projects within the organization. You will be responsible for coordinating various tasks related to regulatory submissions and compliance, ensuring that projects are completed within set timeframes while adhering to stringent industry standards and regulations. This role is perfect for individuals with exceptional attention to detail and strong project management skills. Working closely with cross-functional teams, you will allocate resources efficiently and manage communication streams to ensure precise and timely compliance with regulations. This position offers sign...

As a Compliance Officer at ParaaCrypto, you will play a vital role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be responsible for ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will collaborate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have at least 5 years of experience in compliance, pre...

As the Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be responsible for ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will coordinate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have a minimum of 5 years of experience in complian...

Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally over 50 countries. The company has been consistently ranked amongst the top five pharmaceutical companies in India, with a portfolio that includes renowned brands like Clavam, Pan, Pan-D, and Taxim-O, which are among the top 50 pharmaceutical brands in the country. As a Medical Advisor at Alkem Laboratories Limited, your primary role will be to actively contribute to the organization by ensuring the scientific, technical, and ethical soundness of all policies, statements, and endeavors....

We are looking for a dynamic Chartered Accountant (Fresher) to join our Compliance and Taxation Team . This is a hands-on role focused on direct and indirect tax compliance , tax audits , and regulatory filings across India and international jurisdictions . If youre looking to build deep expertise in tax & finance at one of India’s leading fintech SaaS companies, this is the opportunity for you. Key Responsibilities: Prepare and file GST, VAT, TDS/TCS, Equalization Levy returns Assist in income tax computations , advance tax , and tax audit reports Support Transfer Pricing documentation, policies, and forms Handle tax assessments, appeals , and appear before tax authorities as required Recon...

Dossier Preparation & Compilation: Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations. Regulatory Strategy & Market Compliance: Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions. Bioequivalence Studies & Compliance: Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions. Product Lifecycle Management: Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance. Product Registration &...

Qualification: M.Sc. / M.Pharm / Ph.D. in Life Sciences, Biomedical Sciences, Biotechnology, or a related field Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR. The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products. In addition to EU IVDR compliance, the candidate will support global product registration efforts , including preparation of regulatory documentation for submission in multiple markets. The role requ...

As a Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will include acting as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. You will be tasked with ensuring compliance with Indias VDA regulations and global best practices, updating internal SOPs, and maintaining regulatory documentation. Additionally, you will collaborate with legal, tech, and operations teams on compliance escalations. To excel in this role, you should have a minimum of 5 years of experience in compliance, p...

As a Compliance Officer at ParaaCrypto, you will play a crucial role in leading regulatory engagement, ensuring ongoing FIU compliance, and overseeing all AML/CFT frameworks. Your responsibilities will involve direct reporting to the FIU (Financial Intelligence Unit of India), enforcing internal policies, and monitoring risks proactively. You will act as the primary liaison between ParaaCrypto and FIU-IND, overseeing AML/CFT processes, transaction monitoring, and STR filings. It will be your responsibility to ensure compliance with Indias VDA regulations and global best practices. Additionally, you will be updating internal SOPs, maintaining regulatory documentation, and coordinating with le...

Role & responsibilities 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. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier...