Regulatory Affairs Lead, Project Manager
4 days ago
About the Role We are looking for a Regulatory Affairs Lead/ Project Managerto 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.
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Regulatory affairs manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , Next Gen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
3 weeks ago
New Delhi, India Self-employed Full timeCompany DescriptionFounded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
2 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
2 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
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Regulatory Affairs Manager
1 week ago
New Delhi, India Kimirica Hunter International Full timeJob Title: Manager – Regulatory and ComplianceLocation: IndoreDepartment: Regulatory AffairsRole Overview:Kimirica Hunter International is seeking a highly skilled Manager – Regulatory and Compliance to lead and oversee the compliance function for our diverse product portfolio. The ideal candidate will bring extensive expertise in regulatory requirements...
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Senior manager regulatory affairs
4 weeks ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory Affairs Qualification: M. Sc. / Ph. D. (Life Sciences, Biotechnology, or related discipline) Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (Lat Am, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and...
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Senior Manager Regulatory Affairs
1 week ago
New Delhi, India Panacea Biotec Full timePosition:Sr. Manager / AGM – Regulatory Affairs Qualification:M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline) Experience:13–16 years in Regulatory Affairs (vaccines/biologicals) Role: The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
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Regulatory Affairs Manager
4 days ago
New Delhi, India Kimirica Hunter International Full timeJob Title:Manager – Regulatory and ComplianceLocation:Indore Department:Regulatory AffairsRole Overview: Kimirica Hunter International is seeking a highly skilledManager – Regulatory and Complianceto lead and oversee the compliance function for our diverse product portfolio. The ideal candidate will bring extensive expertise in regulatory requirements...
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Senior Manager Regulatory Affairs
3 weeks ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory AffairsQualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
