About Artixio Artixio is a global regulatory and compliance consulting and solutions company serving the pharmaceutical, biotechnology, medical device, and healthcare industries. We enable life sciences organizations to achieve faster market access and seamless regulatory compliance through expert consulting, intelligent tools, and data-driven strategies. We take pride in our customer focused approach and impatient drive for innovation string for excellence in the industry. Role Overview We are now seeking a dynamic and motivated Regulatory Client Solutions / Presales Professional to join our growing team. In this role, you will work at the intersection of regulatory science, business development, and solution design. You will support client engagements, conduct requirement discovery, and collaborate with internal teams to propose the right-fit regulatory services and solutions to prospective clients. Key Responsibilities Collaborate with business development and regulatory teams to understand client requirements and design customized service proposals Participate in client discovery meetings and calls to capture needs across product categories (pharmaceuticals, medical devices, cosmetics, etc.) and regions Prepare and deliver technical presentations, proposals, and solution documentation tailored to client needs Coordinate with regulatory affairs subject matter experts (SMEs) to scope services, timelines, and deliverables Support RFP/RFI responses and solution positioning with relevant regulatory insights Maintain updated knowledge of global regulatory frameworks, trends, and Artixio’s service portfolio Contribute to internal knowledge repositories, proposal templates, and pitch decks Provide inputs to marketing, product, and tech teams on evolving client requirements and industry trends Required Qualifications Bachelor’s degree or higher in Life Sciences, Pharmacy, Regulatory Affairs, or a related field 2–5 years of experience in regulatory affairs, presales, client solutions, or consulting roles in the life sciences domain Strong understanding of regulatory processes across global markets (e.g., US FDA, EU EMA, CDSCO India, ASEAN, etc.) Experience interacting with clients, preparing proposals, or supporting business development functions Excellent communication and presentation skills – both verbal and written Proficiency in MS Office tools (especially PowerPoint, Excel) and CRM or proposal management tools Preferred Skills (Good to Have) Exposure to regulatory technology platforms (RA database, eCTD tools, labeling systems, etc.) Prior experience in a consulting firm, CRO, or regulatory intelligence company Ability to work across cross-functional teams and handle multiple projects in parallel Why Join Artixio? Work with a fast-growing, innovation-led regulatory services company Exposure to diverse projects across geographies and product categories Collaborate with global teams of regulatory and technical experts Opportunity to grow into strategic consulting, product management, or client leadership roles To Apply Send your updated CV and a brief note explaining your interest in the role to [info @artixio.com ] with the subject line: “Application – Regulatory Client Solutions / Presales Professional” .
We are seeking a motivated and detail-oriented Regulatory Affairs Associate to support regulatory submissions and project coordination activities across RoW (Rest of World) markets - APAC, LATAM and others. The ideal candidate will have foundational experience in pharmaceutical regulatory submissions, authoring technical dossiers, and managing cross-functional timelines. Exposure to OTC and consumer healthcare products is a plus. Key Responsibilities: Prepare, review, and compile high-quality regulatory submissions (CTD/eCTD) for pharmaceutical products in RoW regions (e.g., LATAM, MENA, Southeast Asia, CIS). Collaborate with cross-functional teams including R&D, QA, Manufacturing, and Commercial to ensure timely submission and regulatory compliance. Track submission timelines, regulatory deliverables, and health authority queries using project management tools. Author regulatory documents such as Module 1 forms, Module 2 summaries, and responses to health authority queries. Support product lifecycle management through variations, renewals, and line extensions. Assist in regulatory intelligence gathering and maintaining up-to-date knowledge of regulatory requirements in key RoW markets. Provide support for regulatory activities related to OTC or consumer health products, including label reviews and local submissions. Qualifications: Bachelor’s degree or higher in Pharmacy, Life Sciences, Chemistry, or a related field. 2–3 years of experience in regulatory affairs within the pharmaceutical or consumer health industry. Hands-on experience with regulatory submissions in RoW markets. Understanding of CTD structure, dossier compilation, and basic regulatory processes. Familiarity with project management practices and tools. Strong written and verbal communication skills. Detail-oriented with strong organizational and time management abilities. Knowledge of OTC/cosmetic regulations is an added advantage. Preferred Skills: Ability to multitask and work in a fast-paced environment. Basic knowledge of CTD. ACTD, ICH guidelines and global regulatory frameworks.
About Us: At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation. Key Responsibilities: Collect, review, and organize regulatory data from public health authority sources (e.g., US FDA, EMA, CDSCO, HSA, TFDA, NPRA, etc.). Extract and compile information on product approvals, classifications, guidelines, and regulatory requirements across markets. Maintain and update regulatory databases, trackers, and internal documentation with a high degree of accuracy. Perform periodic audits and quality checks to ensure data completeness, consistency, and compliance. Support regulatory affairs team in preparing documentation, summaries, and reports for internal and client-facing projects. Monitor and log updates in regulatory procedures, timelines, and dossier requirements from official sources. Required Skills & Qualifications: Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, Public Health, or a related field. 1–3 years of experience in regulatory affairs, data entry/management, or scientific documentation. (Freshers with strong skills may also apply.) Strong organizational and analytical skills with high attention to detail. Familiarity with regulatory authorities and global submission processes is preferred. Proficiency in MS Excel, Google Sheets; ability to handle structured data. Strong written communication skills and documentation discipline. Preferred Attributes: Interest in regulatory affairs, compliance, and document/data lifecycle management. Experience working with regulatory agency databases such as Drugs@FDA, EMA, or similar.
About Us: At Artixio, we work at the intersection of regulatory science, healthcare data, and technology. We are building next-generation platforms and solutions that make regulatory information more accessible, structured, and actionable for global pharmaceutical, biologics, and medical device companies. We are looking for a Data Scientist who is passionate about solving complex problems through data-driven approaches and machine learning. Key Responsibilities: Analyze structured and unstructured regulatory and healthcare datasets to derive insights, patterns, and predictive models. Design, develop, and validate machine learning models for use cases such as classification, document processing, recommendation systems, and effort estimation. Work with NLP techniques to extract and normalize information from regulatory texts, product labels, and public databases. Develop data pipelines and workflows to clean, transform, and prepare datasets for analysis and modeling. Collaborate with cross-functional teams including software developers, regulatory experts, and product managers to implement data science solutions in real-world applications. Monitor model performance, conduct error analysis, and continuously improve algorithm accuracy and efficiency. Contribute to research, publications, or internal white papers around regulatory data science and analytics. Required Skills & Qualifications: Bachelor’s or Master’s degree in Data Science, Computer Science, Engineering, Statistics, Mathematics, or related fields. 2–5 years of hands-on experience in data science or applied machine learning. Proficiency in Python and libraries such as pandas, scikit-learn, NumPy, TensorFlow, or PyTorch. Strong understanding of supervised and unsupervised learning, NLP techniques, and model evaluation metrics. Experience working with healthcare, life sciences, or regulatory datasets is a strong plus. Familiarity with data cleaning, feature engineering, and data visualization tools (e.g., matplotlib, seaborn, Power BI). Comfortable working in an agile, fast-paced environment with evolving data challenges. Preferred Attributes: Experience with large language models (LLMs), transformers, and foundation model fine-tuning. Background in text classification, named entity recognition (NER), or OCR-based document processing. Exposure to cloud platforms (AWS, GCP, or Azure) and MLOps practices is desirable. Curious, self-driven, and eager to explore new algorithms and technologies.
About Us: At Artixio, we support global pharmaceutical, biologics, and medical device companies in navigating complex regulatory landscapes. We are seeking a detail-oriented and driven Data Associate to support our regulatory information management initiatives by organizing, maintaining, and updating critical regulatory data and documentation. Key Responsibilities: Collect, review, and organize regulatory data from public health authority sources (e.g., US FDA, EMA, CDSCO, HSA, TFDA, NPRA, etc.). Extract and compile information on product approvals, classifications, guidelines, and regulatory requirements across markets. Maintain and update regulatory databases, trackers, and internal documentation with a high degree of accuracy. Perform periodic audits and quality checks to ensure data completeness, consistency, and compliance. Support regulatory affairs team in preparing documentation, summaries, and reports for internal and client-facing projects. Monitor and log updates in regulatory procedures, timelines, and dossier requirements from official sources. Required Skills & Qualifications: Bachelor's degree in Pharmacy, Life Sciences, Regulatory Affairs, Public Health, or a related field. 1-3 years of experience in regulatory affairs, data entry/management, or scientific documentation. (Freshers with strong skills may also apply.) Strong organizational and analytical skills with high attention to detail. Familiarity with regulatory authorities and global submission processes is preferred. Proficiency in MS Excel, Google Sheets; ability to handle structured data. Strong written communication skills and documentation discipline. Preferred Attributes: Interest in regulatory affairs, compliance, and document/data lifecycle management. Experience working with regulatory agency databases such as Drugs@FDA, EMA, or similar.,
About Artixio: Artixio is a global regulatory and market access consulting company specializing in pharmaceuticals, biologics, medical devices, nutraceuticals, cosmetics, and veterinary products. We support life sciences organizations worldwide with high-quality regulatory and business documentation. To maintain the clarity and professionalism of our content, we are seeking a meticulous Proofreader to join our team. Key Responsibilities: Review documents for grammar, spelling, punctuation, and language consistency. Ensure clarity, flow, and readability across business, regulatory, and client-facing documents. Maintain consistency in formatting and style according to company standards. Work closely with team members to deliver polished, error-free documents. Handle multiple assignments while adhering to deadlines. Requirements: Bachelor’s degree in English, Communications, or related field. Proven experience as a proofreader or editor. Strong command of the English language with keen attention to detail. Familiarity with common style guides (APA, Chicago, AMA, etc.) preferred. Ability to work independently and manage multiple priorities effectively. Nice to Have: Experience proofreading business, consulting, or professional service documents. Exposure to content in life sciences or regulatory industries (not required). Why Join Artixio: Work with a fast-growing global consulting firm. Contribute to high-quality client deliverables across diverse projects. Collaborative and supportive team culture. Flexible working model with opportunities to work across international projects.
About the Role We are looking for a Regulatory Affairs Lead/ Project Manager to join our dynamic team. The ideal candidate is a passionate regulatory professional with hands-on experience in preparing and submitting applications to Health Authorities in Asia, LATAM, or other international markets. This role requires strong leadership, high attention to detail, and the ability to thrive in an entrepreneurial environment. Key Responsibilities Manage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global Markets Plan and Prepare Regulatory Project Plans/Submission Strategies Lead regulatory submissions and manage interactions with Health Authorities across multiple regions. Identify regulatory gaps, assess risks, and provide clear guidance to cross-functional teams. Work closely with Regional Regulatory Experts, Provide Directions, Identify Gaps and Provide Strategic Direction Act as the primary point of contact for clients, ensuring proactive and effective communication. Drive project planning, execution, and monitoring to ensure timely and compliant delivery. Collaborate with business development teams to support proposals and regulatory strategy discussions. Mentor and guide junior team members, fostering a culture of excellence and accountability. Qualifications 4–7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors. Deep Understanding of Client Strategic Requirements against Global Regulatory and Documentation Requirements Proven track record of preparing and submitting applications to regional/global Health Authorities. Strong client-facing and stakeholder management skills. Entrepreneurial mindset: self-starter, problem-solver, and capable of driving initiatives independently. Excellent organizational, communication, and leadership skills. Why Join Us Opportunity to work on diverse global projects across multiple markets. Collaborative, growth-oriented, and innovative work culture. A platform to take ownership, lead client interactions, and contribute to global healthcare access.
About the Role We are seeking a Scientific / Regulatory Content Writer with 4–7 years of proven experience in developing high-quality content in the scientific, medical, or regulatory domains. The ideal candidate will have exceptional writing skills , a keen eye for detail, and the ability to transform complex topics into clear, engaging, and evidence-based content. This role requires leadership , the ability to manage multiple content streams, and collaboration across cross-functional teams. Key Responsibilities Research, draft, and edit high-quality content primarily for regulatory domains, with few scientific and medical content. Ensure all content is evidence-based , validated, and aligned with industry standards. Proofread and maintain consistency in tone, structure, and accuracy across deliverables. Manage multiple content projects simultaneously, ensuring timely delivery. Provide editorial leadership, guidance, and mentorship to content teams. Collaborate with regulatory, scientific, and business development teams to align content with organizational objectives. Apply SEO best practices (where applicable) to enhance visibility and reach. Qualifications 4–7 years of experience in scientific, medical, or regulatory content writing. Strong command of the English language, grammar, and scientific communication. Demonstrated ability to create accurate, compelling, and audience-friendly content. Proven experience in proofreading, validation, and evidence-based writing. Strong project management and multitasking skills. Leadership abilities to manage and guide content workflows. Understanding of SEO concepts (preferred but not mandatory). What We Offer Opportunity to work on diverse global scientific and regulatory content projects. Collaborative, innovative, and growth-oriented work environment. Exposure to cross-functional teams across regulatory, medical, and business domains. Platform to take ownership of content strategy and make a global impact. Interested candidates can apply directly via LinkedIn or reach out to us to learn more.
About the Role We are looking for a Medical Device Regulatory Lead with 4–6 years of proven hands-on experience in medical device regulatory submissions and compliance. The ideal candidate will have strong expertise in preparing and submitting applications to Health Authorities including US FDA (510k), Europe (CE Marking), MDSAP, CDSCO , and other global regulatory agencies. This role requires leadership, ownership, and the ability to guide cross-functional teams through complex regulatory pathways. Key Responsibilities Lead the preparation, submission, and management of medical device applications (US FDA 510k, CE Marking, MDSAP, CDSCO, and other markets). Ensure compliance with regulatory standards including ISO 13485, 21 CFR 820 , and other applicable regulations. Act as the primary contact for Health Authorities, managing queries and responses effectively. Oversee regulatory strategy, project planning, and execution for medical device submissions. Provide guidance on Quality Management Systems (QMS) and support audits/inspections. Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Clinical, Commercial) to align regulatory requirements with business objectives. Take ownership of projects, demonstrating leadership and accountability in delivery. Qualifications 4–6 years of experience in medical device regulatory affairs . Proven track record with submissions to FDA (510k), CE Marking, CDSCO, and other agencies . Strong knowledge of ISO 13485, 21 CFR 820, QMS practices, and international medical device regulations . Experience in responding to Health Authority queries and managing regulatory communications. Excellent project management, organizational, and leadership skills. Ability to work independently, take ownership, and drive results. Why Join Us Opportunity to lead regulatory projects across global markets. Work in a dynamic, entrepreneurial, and collaborative environment. Be at the forefront of advancing compliance and patient safety in medical devices. Apply now via LinkedIn or connect with us to explore this opportunity
You are being sought after to take on the role of Regulatory Affairs Lead/ Project Manager, joining a dynamic team that values passionate regulatory professionals. Your main responsibilities will include managing regulatory projects for Pharmaceuticals, Biologics, Medical Devices, and other products in Global Markets. You will be expected to plan and prepare regulatory project plans/submission strategies, lead regulatory submissions, manage interactions with Health Authorities across multiple regions, and provide clear guidance to cross-functional teams by identifying regulatory gaps and assessing risks. Additionally, you will work closely with Regional Regulatory Experts, act as the primary point of contact for clients, drive project planning and execution, collaborate with business development teams, and mentor junior team members to foster a culture of excellence and accountability. Qualifications you should possess for this role include having 4-7 years of experience in regulatory affairs and project management within the pharmaceutical, biotech, or medical device sectors. You should have a deep understanding of client strategic requirements against global regulatory and documentation requirements, a proven track record of preparing and submitting applications to regional/global Health Authorities, strong client-facing and stakeholder management skills, and an entrepreneurial mindset with excellent organizational, communication, and leadership skills. In addition to the role specifics, this opportunity offers you the chance to work on diverse global projects across multiple markets in a collaborative, growth-oriented, and innovative work culture. You will have a platform to take ownership, lead client interactions, and contribute to global healthcare access.,
Company Description Artixio is a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance. We support pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers in global regulatory compliance, product commercialization, and post-approval processes. Our services extend to compliance, regulatory intelligence across 70+ countries, product/label compliance and registration, and market lifecycle management. We also offer comprehensive communication services, including scientific literature development, public relations, and social media management. Role Description This is a full-time on-site role for a Data Coordinator located in Hyderabad. The Data Coordinator will be responsible for managing and analyzing data, performing data analytics, and ensuring effective data management. This role involves daily tasks such as data entry, maintaining databases, troubleshooting data issues, and providing insights through data analysis. The Data Coordinator will also engage in communication within the team and report findings to relevant stakeholders. Qualifications Analytical Skills and Data Analytics Data Management and Data Analysis skills Strong Communication skills Attention to detail and problem-solving skills Bachelor's degree in related field or equivalent experience Experience in the pharmaceutical or biotech industry is a plus