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2 Job openings at ArtiXio
Regulatory Client Solutions / Presales Lead

Hyderabad, Telangana, India

5 years

None Not disclosed

On-site

Full Time

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” .

Regulatory Affairs Associate

Hyderabad, Telangana, India

3 years

None Not disclosed

On-site

Full Time

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.

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