Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com 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 to 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.

Must Have

ROLE PURPOSE:  Candidate need to have submission publishing experience with global regulatory submission formats ACTD/eCTD/ /NeeS/Paper dossiers format, for EU, MENA & ASEAN markets
SKILLS: 
•    Hands-on experience in ISI Toolbox, Lorenz Docubridge & Trackwise
•    Hands on experience on RIMS preferably Veeva Vault
•    Good communication skills (Written and Oral)
•    MS Office (Excel and Power point), Adobe Professional, ISI Toolbox
PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES:

•    Experience with global regulatory submission formats, including familiarity with submission publishing activities
•    Thorough knowledge of major HA global/regional/national country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management 
•    Perform document-level and dossier publishing. Prepare and compile global regulatory dossiers in ACTD, eCTD and non eCTD format in accordance with EMA/ASEAN HA legislations and client specific requirements
•    Excellent working knowledge of regional regulations and guidance as it pertains to format and submission structure required. Understand, interpret, and apply Agency regulations and guidelines related to submissions
•    Thorough understanding of all aspects of the publishing software, tools, process, and output requirements.
•    Performs eCTD readiness/pre-publishing tasks (i.e., formatting and document navigation) and assist Medical Writers in the development and compilation of appendices and publishing of various regulatory documents
•    Perform publishing QC tasks within the electronic publishing system and QC of the published output to ensure high submission quality. Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution.
•    Operates in compliance with regulations, company policies, procedures, and processes. 
•    Analyze challenges/limitations in dossier publishing and provide logical, unbiased and rational recommendations for modifying quality standards or introducing newer ones
•    Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation
•    Stay updated with evolving regulatory requirements and industry trends and able to extract regulatory intelligence information (requirements for initial filing, drug/device/cosmetic/food registration etc.)
•    Participate in trainings and learn through hands-on experience on the job
•    Exhibit flexibility in moving across new projects and preparing multiple document types
•    Continuously enhance and maintain knowledge of various regulatory guidelines for different deliverables by doing various assignments
•    Volunteer in training programs to develop skills in areas relevant to the job in addition to the areas of interest

EDUCATION: BPharm / MPharm/ Pharm D/ MSc

EXPERIENCE:  Required 4-8 years of experience Publishing (document-level and dossier)

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. 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.