Indegene is a global leader in providing innovative solutions for the biopharmaceutical, emerging biotech, and medical device industries. With expertise in healthcare, cutting-edge technology, and agile methodologies, Indegene helps companies navigate the complexities of product development, market entry, and lifecycle management. The company’s mission is to drive efficient, scalable, and omnichannel solutions for patients and physicians, fostering a future-ready healthcare ecosystem. As part of this vision, Indegene is seeking a talented Regulatory Solutions Associate Manager to join its dynamic team in Bangalore.
Responsibilities in the Regulatory Solutions Associate Manager Role
As a Regulatory Solutions Associate Manager at Indegene, you will be responsible for overseeing and delivering high-quality clinical regulatory writing services. Your primary duties will include:
- Document Preparation and Review: Independently preparing and reviewing regulatory documents such as clinical study reports, protocols, investigator brochures, and submission documents (Module 2 summaries) for investigational drugs at various stages of clinical development.
- Lean Authoring and Structured Content Management: Utilizing lean authoring principles and structured content management libraries to streamline the document development process.
- Project Coordination: Leading document review activities, facilitating consensus meetings, and ensuring the timely finalization of documents under tight deadlines.
- Team Leadership: Managing and mentoring junior writers, coordinating with cross-functional teams, and ensuring adherence to standard processes and messaging.
- Regulatory Research: Staying updated on current regulatory requirements across various regions, ensuring that all documentation aligns with global regulatory guidelines.
- Training and Knowledge Sharing: Contributing to departmental initiatives, sharing best practices, and providing training to junior team members to enhance their skills and knowledge.
Qualifications Required for the Role
To be considered for the Regulatory Solutions Associate Manager position at Indegene, candidates must meet the following qualifications:
- Educational Background: A professional degree such as MBBS, PhD, MDS, BDS, MPharm, or PharmD.
- Experience: 10 to 12 years of experience in writing clinical and regulatory documents supporting global filings, particularly with expertise in CTD Modules 2 and 5.
- Scientific Knowledge: A strong understanding of regulatory guidelines and the ability to interpret scientific data for document writing, including clinical study reports, protocols, and investigator brochures.
- People Management Experience: At least 2 years of experience managing teams and mentoring junior members.
- Technology Proficiency: Proficient in MS Word, document management systems, and the use of various tools for document preparation and management.
Key Skills for Success in the Role
The ideal candidate for this position will possess the following skills:
- Clinical and Regulatory Expertise: Deep understanding of the clinical development process, including trial design and regulatory requirements.
- Communication and Leadership: Strong communication skills for leading cross-functional teams, facilitating meetings, and ensuring alignment on project goals and timelines.
- Time Management and Organizational Skills: The ability to manage multiple tasks, prioritize work effectively, and ensure timely delivery of documents.
- Adaptability: Flexibility to work across different therapeutic areas and adapt to evolving business needs.
- Process-Oriented: Comfortable working within structured processes, templates, and guidelines for document preparation and review.
How to Apply for the Regulatory Solutions Associate Manager Position
If you meet the qualifications and are interested in joining Indegene as a Regulatory Solutions Associate Manager, we encourage you to apply by following these steps:
- Prepare Your Application: Ensure your resume highlights your relevant experience in regulatory writing, clinical documentation, and team management.
- Submit Your Application: Apply directly through Indegene’s careers page or reach out to the HR department for further guidance.
- Follow Up: After submitting your application, you may be contacted for an interview, during which you will have the opportunity to showcase your expertise and leadership abilities.
Application Deadline: February 25, 2025