Regulatory Affairs Lead, Project Manager
2 weeks ago
About the RoleWe 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 ResponsibilitiesManage Clients' Regulatory Projects for Pharmaceuticals, Biologics, Medical Devices and other products in Global MarketsPlan and Prepare Regulatory Project Plans/Submission StrategiesLead 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 DirectionAct 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.Qualifications4–7 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 RequirementsProven 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 UsOpportunity 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.
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Regulatory Affairs Lead, Project Manager
4 weeks ago
Hyderabad, Telangana, India, Telangana ArtiXio Full timeAbout 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...
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Regulatory Affairs Lead, Project Manager
4 weeks ago
Hyderabad, India ArtiXio Full timeAbout 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...
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Regulatory Affairs Lead, Project Manager
4 weeks ago
Hyderabad, India ArtiXio Full timeAbout 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...
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Hyderabad, India ArtiXio Full timeAbout 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...
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Regulatory Affairs Manager
3 days ago
Hyderabad, Telangana, India Amgen Inc Full time ₹ 1,20,000 - ₹ 2,40,000 per yearJob Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a...
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Regulatory Affairs IT Architect
3 weeks ago
Hyderabad, India beBeeTechnical Full timeSenior Technical Solution Specialist Create innovative IT solutions and services to meet quality and performance requirements and technical constraints. About the Role This position requires a consultant and advisor to improve complex global business processes, products, and services in Regulatory Affairs. Lead technical activities for transformative...
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Regulatory Affairs Manager
1 week ago
Hyderabad, Telangana, India Revio Therapeutics Full time ₹ 12,00,000 - ₹ 24,00,000 per yearRole DescriptionRevio Therapeutics is seeking a seasoned Regulatory Affairs Manager with 10–15 years of experience to oversee all regulatory activities across development and registration of our 505(b)(2)/Hybrid programs. This role requires deep understanding of US FDA regulations, guidances as well as for other regulated markets. The candidate should have...
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Regulatory Affairs Specialist
1 week ago
Hyderabad, Telangana, India Morulaa HealthTech Pvt. Ltd. Full timeCompany DescriptionMorulaa HealthTech Pvt. Ltd. was founded to assist in the commercialization of bio-science technologies and the growth of healthcare companies. Based in Ohio and collaborating with Cleveland Clinic, University Hospitals, and Case Western Reserve University, Morulaa specializes in the Registration of Medical Devices and Distributor...
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Regulatory Affairs
2 weeks ago
Hyderabad, Telangana, India Clininfotech Full time ₹ 4,00,000 - ₹ 6,00,000 per yearWe are seeking a Regulatory Affairs Executive Freshers To Work in the MNC For Hyderabad LocationThe ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Required Candidate profileB.Pharm & M.Pharm With Knowledge of Regulatory Affairs CTD ECTD DMF and Regulatory Guidelines are...
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Regulatory Affairs Manager
6 days ago
Hyderabad, Telangana, India Shri Kartikeya Pharma Full time ₹ 5,00,000 - ₹ 15,00,000 per yearJob Summary:The Regulatory Affairs Manager will oversee all regulatory compliance activities related to the companys nutraceutical products, ensuring that all the marketing practices meet applicable global standards (e.g., FDA (U.S.), EFSA (EU), FSSAI (India).Key Responsibilities:Regulatory Strategy & Compliance.Develop and implement regulatory strategies...
