Associate - Regulatory Solutions

Looking to jump-start your career?

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth.

We are purpose-driven.** **We enable healthcare organizations be future ready and our customer obsession is our driving force**.** We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc

EXPERIENCE: 2 to 4 years of Regulatory Writing

Key requirement:

- Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents
- Experienced in the development of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively
- Experience in document formatting
- Experience in literature search
- Good understanding of clinical trial and product life cycle

LOCATION: Bangalore (Office-based/Hybrid)

ROLE PURPOSE:

- Develop content for various regulatory documents; ensure quality as per set regulatory standards and compliance requirement.
- Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format.

SKILLS:

- Good communication skills (Written and Oral)
- MS Office (Excel and Power point)

PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES:

- Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects)
- Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD)
- Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development
- Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development
- Conduct quality checks to ensure the accuracy and consistency of data included in documents
- Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas
- Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism
- Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation and technical requirements like language, grammar, style, content search, summarizing, data conflicts and referencing
- Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones
- Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective
- Broad area-2: Process Adherence and Compliance
- Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy
- Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client
- Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms
- Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines
- Broad Area-4: Self-Development
- Support in developing technical training programs for other team members relevant to the job
- Responsible to complete client-specific training, if applicable
- Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas

**EQUAL OPPORTUNITY**

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.