225 Regulatory Documentation Jobs - Page 4

preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission Preparation of respective CTD sections and submission of final query response to agency Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval To upload documents in national portal for respective European regulatory agency Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation Review of the mockups for all regulatory submissions and commercial supplies Maintenance of internal database Co-ordination with consulta...

As an MD in Microbiology, your role will involve preparing SOPs, protocols, and documentation for ongoing studies. You will be responsible for coordinating with other departments to meet clinical and laboratory requirements. Your key responsibilities will include ensuring ethical compliance and regulatory documentation as per standards. Qualifications Required: - MD in Microbiology - Prior experience in preparing SOPs and protocols - Strong understanding of ethical compliance and regulatory standards Please note that this is a contractual/temporary position and the work location is in person.,

As a Pathology MD working on a contractual/temporary basis, your role will involve preparing SOPs, protocols, and documentation for ongoing studies. You will be responsible for coordinating with other departments to meet clinical and laboratory requirements. Additionally, you will play a key role in ensuring ethical compliance and regulatory documentation in accordance with standards. **Key Responsibilities:** - Prepare SOPs, protocols, and documentation for ongoing studies - Coordinate with other departments for clinical and laboratory requirements - Ensure ethical compliance and regulatory documentation as per standards **Qualifications Required:** - MD in Pathology - Relevant experience i...

As a Regulatory Affairs Manager at Ferring India Laboratories, you will be responsible for the following key responsibilities: - Prepare, compile, and submit regulatory dossiers and submission data. - Manage Test and Manufacturing License applications with state and central drug authorities. - Handle regulatory submissions, variation filings, technical report writing, and query responses. - Ensure compliance with Drugs & Cosmetics Act, New Drug & Clinical Trial (CT) Rules, and GMP guidelines. - Ensure adherence to national and international regulatory requirements. - Review product labeling and artworks for regulatory compliance. - Liaise with state and central regulatory bodies (e.g., CDSCO...

As a Research Coordinator at Jothydev's Diabetes Research Centre, your role will involve assisting in trial management and site coordination, maintaining Trial Master Files (TMF) with proper documentation, and ensuring regulatory compliance. You will also be responsible for drug storage, dispensing, and accountability, as well as supporting patient enrollment and clinical trial material logistics. Additionally, you will schedule meetings, prepare agendas and minutes, demonstrating your technical and soft skills including knowledge of ICH-GCP guidelines, proficiency in Microsoft Office and clinical trial software, and strong organizational and communication abilities. Qualifications required ...

Role Overview: You will be responsible for planning and managing medical writing for Regulatory and Pharmacovigilance Verticals in compliance with applicable regulatory guidelines. Your main duties will include providing high-quality medical and scientific writing, offering technical consultation, demonstrating subject matter expertise, managing medical writing projects, collaborating with internal and external clients, and ensuring document output compliance with client specifications. Key Responsibilities: - Provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. - Offer techn...

Role Overview: You will be responsible for preparing consistent and high-quality technical documents related to Pharmaceutical Research and Development for Formulation at Teva. Your role will involve executing all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs, and SOPs. Maintaining open communication with R&D members to ensure timely delivery of high-quality documents independently with minimal supervision will be a key aspect of your responsibilities. Key Responsibilities: - Prepare documents and facilitate documentation management in R&D while ensuring correctness, completeness, and clarity following established guidelines. - Prepare documen...

A policy & regulatory leadership role in a evolving renewable energy sector Be part of an organization shaping India's clean energy transition. Job Description The ideal candidate will lead policy research, regulatory analysis, and advocacy efforts in alignment with the company's renewable business strategy. The role includes tracking central and state-level regulations, managing regulatory filings and compliance, and representing the organization in key forums, consultations, and industry associations. The Successful Applicant 10-15 years of experience in policy, regulatory affairs, or energy law within the renewable energy or power utility sector. Strong knowledge of open access, FDRE, RTC...

Lead the entire liaisoning function for a major Indian carbon company. High-impact role ensuring strategic regulatory compliance in Bangalore . Job Description Develop and implement a comprehensive Liaisoning strategy aligned with corporate goals and regulatory needs. Serve as the senior point of contact for all government and statutory authorities. Oversee the acquisition and timely renewal of all statutory clearances (CTE/CTO, fire NOCs, hazardous waste). Ensure zero non-compliance through timely internal audits and preparation for external inspections. Build and maintain strong relationships with local government, municipal bodies, and community leaders. Collaborate with internal departme...

Role: Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics) Primary purpose of the role: The role of GRO Regulatory Data Analytics is to: Manage Teva's data in accordance with requirements for xEVPMD in order to maintain Teva's Article 57 compliance Provide a Central Data Service for the creation and maintenance of GRA product registration data in line with the global needs of Teva Global Regulatory Affairs. Provide SME services for data management in current and future regulatory data systems The primary purpose of this position is to execute the operations and services applicable to the GRO Regulatory Data Analytics role in line with business goals and objectives...

Company Description Dyaz Innovate is a software company with its flagship product, DyazRIMS, which supports the entire regulatory compliance process. The company is committed to enhancing regulatory processes for clients globally and promotes an engaging and supportive work environment. Role Description This is a full-time on-site role for a Senior Regulatory Affairs Specialist, located in Hyderabad . The Senior Regulatory Affairs Specialist will be responsible for managing regulatory documentation, ensuring regulatory compliance, overseeing regulatory submissions, and staying updated with regulatory requirements. This role involves coordinating with various departments to ensure all regulat...

Please share your resume at anita.searchrx@gmail.com Role & responsibilities Preparation, compilation, and review of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs) for submission to various regulatory authorities (USFDA, EDQM, TGA, PMDA, etc.). Handle query responses from global regulatory agencies and ensure timely and accurate replies. Coordinate with R&D, Quality Assurance, Quality Control, and Production teams for regulatory data collation. Review of technical documents such as specifications, analytical methods, process descriptions, and stability data. Support in the preparation of Annual Product Reviews and Post-Approval Changes . Maintain and update regulatory dat...

As a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, you are encouraged to apply for this exciting opportunity. Your impact will involve utilizing your minimum 2 years of experience in medical writing or equivalent experience in the life sciences domain. Specifically, you will be responsible for the End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports. Key Responsibilities: - End-to-End authoring of periodic aggregate reports such as PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports ...

As a Regulatory Affairs Associate at Vamsi Pharma Pvt. Ltd. (VPPL), your role involves handling regulatory documentation and submissions to regulatory authorities. You will be responsible for ensuring that all regulatory requirements and compliance standards are met. This includes monitoring and interpreting regulatory updates and changes to adapt processes accordingly. Your duties will also include ensuring product compliance with all relevant standards and regulations, as well as developing product artwork for new products based on specific requirements. Collaboration with cross-functional teams is essential to ensure regulatory compliance in product development. Key Responsibilities: - Ha...

Role & responsibilities Dossier and regulatory document preparation Regular discussion and interactions with customer's regulatory team to answer queries regarding documentations Visiting FDA office for follow ups on applications Preferred candidate profile Deep knowledge of regulatory frameworks in Southeast Asia (especially the ACTD structure), Africa, and Latin America, and ability to interpret country-specific requirements for dossier submissions. Proficiency in preparing, compiling, and presenting regulatory dossiers (including administrative, quality, nonclinical, and clinical sections) according to the ACTD and local formats. Strong documentation management, including version control,...

You will be joining the Formulation R&D team at Hetero Drugs as a Scientist II, focusing on the development of sterile injectable formulations, including aqueous, non-aqueous, lyophilized, and peptide-based oncology products. Your role will be crucial in advancing product development for regulated markets such as the US, Europe, and ROW. You will be responsible for comprehensive formulation design, process optimization, regulatory documentation, and coordination across departments. - Independently lead the development of sterile injectable products, including aqueous, non-aqueous, lyophilized, and peptide-based formulations. - Conduct formulation studies, process optimization, and scale-up a...

Position: Senior Regulatory Affairs Manager Global Cosmetics Compliance Department: Regulatory Affairs / Operations Reports to: COO (Integrator) & CEO Location: India, Noida- Sec- 63 Employment Type: Full-time Shift Time- 12 PM IST- 9 PM IST About CBAYEXPRESS / Herbishh: CBAYEXPRESS CORPORATION is a Canadian-based e-commerce company selling across Amazon (US, CA, MX, UK, EU, AU, SG, IN, UAE), Walmart, Shopify (Herbishh.com, BisonBody.com), eBay, and other marketplaces. Our flagship brand Herbishh is a leader in haircare and beauty, with rapid global expansion. With $15M+ annual revenue, we are scaling towards $30M+ globally, and compliance is a key pillar of our success. Role Overview: We ar...

Role Overview: As a skilled Technical Writer joining the SCM II Technical Publication team, your primary responsibility will be to create clear, concise, and compliant technical content in accordance with regulatory documentation and federal aviation/authority guidelines. Your role will involve configuration management processing, documentation tracking, and software build preparation to ensure department practices align with released procedures. You will also be responsible for analyzing software documentation, resolving discrepancies, and addressing inquiries from customers and field engineering regarding software shipments and distribution requirements. Key Responsibilities: - Verify and ...

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

JOB SUMMARY: Knowledgeable in all disciplines of ecotoxicology, including aquatic, plants, avian, mammals, and terrestrial. Conduct ecotoxicological risk assessments and provide expert guidance to internal colleagues on ecotoxicology issues, including responses to Regulatory decisions, Data Call In reviews and recommendations, and planning defense strategies around ecotoxicology concerns. Experience with interacting with regional Regulatory Agencies especially US-EPA and European Authorities. Familiar with global data requirements, including North America, Brazil, LATAM, and Europe. Contract ecotoxicology studies at external labs. Interpret study results and implications of results. Provide ...

Job Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, referen...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Role & responsibilities You will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database. Location: Gurgaon Key duties and responsibilities Develop regulatory strategy and update the strategy based upon regulatory changes and business needs. Manage and execute regulatory compliance activities as required by the local regulations Compile, prepare, review and submit regulatory submissions to the local health authorities as well as to identify issues early in the submission preparation process that could impact product launch Monitor...

Preparation & compilation of Dossiers Knowledge of UK & EU Market, CTD Review of Artwork. Registration of renewal of products Solve Queries & Timely compile materials for license renewals, updates and registration Review changes to existing products Education PG: M.Pharma in Pharmacy

Role Overview: You will be the Controlled Documentation Lead in the R&D Quality department at Amgen, responsible for managing end-to-end lifecycle of controlled documents to ensure compliance with regulatory standards and internal quality procedures. Your role will involve coordinating document workflows, conducting QC reviews, maintaining document templates, and supporting audits and inspections. Key Responsibilities: - Coordinate and manage document workflows (e.g., SOPs, templates) to meet project timelines and compliance standards. - Track documentation milestones and follow up with contributors to ensure deadlines are met. - Provide technical editing and proofreading support to maintain...