Manager Clinical Affairs

Clinical Affairs Manager Join the Future of Healthcare TC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs billions in healthcare expenses. Our AI-powered app provides a fast, affordable and accurate way to distinguish bacterial from viral infections at the point of care, empowering providers to prescribe responsibly. Through this innovation, we will not only be improving patient care but also contributing to the global fight against drug resistance and the downstream trillion-dollar burden from Rheumatic Heart Disease. Join us in building a healthier future, one diagnosis at a time. About the Role: As the Medical Affairs Manager, you will be instrumental in the clinical development and regulatory strategy for LightAI in India. You will work closely with clinical trial sites, CROs, and regulatory authorities to advance the product pipeline. Key Responsibilities:

• Clinical Trial Management: Design, execution, and monitoring of clinical trials for LightAI, including site selection, patient recruitment, data management, and regulatory compliance.
• Regulatory Affairs: Manage regulatory interactions with CDSCO and other relevant authorities. Prepare and submit regulatory filings, including clinical trial applications, submissions, and post-marketing submissions.
• Medical Writing: Develop clinical study reports, investigator brochures, and other regulatory documents.
• Medical Information: Provide medical information and support to internal and external stakeholders, including healthcare professionals and regulatory agencies.
• Scientific Communication: Present scientific data at conferences and publish in peer-reviewed journals.
• Collaboration: Work closely with cross-functional teams, including clinical operations, regulatory affairs, product development, marketing and commercial teams.

• Advanced degree in medicine, pharmacy, or a related field.
• Strong understanding of clinical research methodologies, regulatory affairs, and medical affairs.
• Extensive experience in managing clinical trials, preferably in the medical device or digital health domain.
• Proven track record of successful regulatory submissions and approvals.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.