Regulatory Manager

You are a technology-led healthcare solutions provider, driven by the purpose to enable healthcare organizations to be future-ready. You offer accelerated global growth opportunities for individuals who are bold, industrious, and nimble. At Indegene, you can experience a unique career journey celebrating entrepreneurship, guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com. Imagine moving to an exciting role in an entrepreneurial organization without the usual risks associated with it. At this stage of your career where growth and variety are important to you, Indegene invites you to join their journey and grow with them. Indegene provides roles that offer both excitement and reliability, trusting you from day one to deliver global impact, lead teams, and take responsibility for outcomes while being supported and mentored by leaders. As a profitable rapidly growing global organization, Indegene is seeking the best talent for its current phase of growth. Working at the intersection of healthcare and technology, you will have access to global opportunities with fast-track careers, collaborating with a purpose-driven team. This combination promises a truly differentiated experience for you. If this opportunity excites you, apply for the position of Associate Manager / Manager - Regulatory Writing (Clinical) at Indegene. **Experience:** You should have 10 to 12 years of experience in writing Clinical & Regulatory documents supporting global filings, specifically CTD Module 2 and Module 5. **Role Purpose:** Your role involves handling complex Medical Writing projects, providing review support for medical writing deliverables that support the clinical regulatory writing portfolio, and training junior writers. **Skills:** - Experience in authoring various clinical document types to support regulatory filings - Lead cross-functional teams to draft scientific/medical content - Understanding of the clinical development process - Effective communication and time management skills - People management experience - Customer focus and ability to work independently - Adherence to structured processes for document delivery - Ability to manage tasks, roles, and responsibilities within the authoring team - Strong knowledge of regulatory guidelines and regional requirements - Ability to interpret data and apply scientific knowledge to support regulatory document writing - Comfortable working on cross-functional teams **Knowledge Requirement:** - Strong scientific knowledge - Understanding of regulatory guidelines/requirements - Ability to interpret data and apply scientific knowledge - Manage messaging for consistency and alignment with strategy **Technology Skills:** - Expert authoring in MS Word - Experience working in document management systems - Capable of training writers/authors on the use of templates and tools **Responsibilities:** Prepare/review clinical study reports without guidance from senior members of the writing staff.,