Associate/ Senior Associate Manager Gra Job In Lilly In India, Bengaluru / Bangalore

Purpose:The purpose of the Associate, GRA-NA, is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients This is accomplished through a strong working knowledge of regulations, guidanceu2019s and regulatory precedence and collegial and mutually productive relationships across Lilly components, partner companies, and within relevant ministries of health The Associate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency, and influence effective change management within GRA and cross-functionally The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application It is expected that this position embrace corporate transformation initiatives and represent Global Regulatory Affairs-NA (GRA-NA) as a change ambassador.

Primary Responsibilities:Provide Regulatory & Drug Development Expertiseu00B7 Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for GRA-NA This includes but us not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTDu00B7 Partner with other geographies to understand and incorporate local agency regulations and requirements as needed For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specificationu00B7 Guide and influence development team and function regarding internal and Agency registration management processes and requirementsu00B7 Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurateRecords include:The IND and NDA submissionsTracking the status of pending applications and commitmentIncoming correspondence and records of contactu00B7 Serve as the GRA-NA operational lead for registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings and GRACRR planningu00B7 Own the routine compliance submissions and processes (e.

g DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissionsu00B7 Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal processu00B7 Provide registration management expertise to the due diligence and business developmentprocessesu00B7 Serve as the registration management expert for other processes dependent upon the registration record (eg.

OSI requests, out-license, user fees/drug listing/orange book)Lead/Influence/Partneru00B7 Develop collaborative relationships with personnel in other Lilly functional areas (eg medical, legal, labeling, compliance, quality, affiliates, etc) to effectively influence the electronic registration plan.

u00B7 Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions and constructively challenge to reach the best solutionsu00B7 Develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate reviewu00B7 Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetingsu00B7 Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertiseu00B7 Influence others in a manner that creates maximum advantage for the organizationu00B7 Communicate verbally and in writing to effectively influence within work group/function and with development teamu00B7 Serve as a mentor within GRAMinimum Qualification Requirements:A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.

Other Information/Additional Preferences:

• MPharm and higher education
• Experience with global regulatory affairs for the US, EU and Canada
• Experience with global regulatory affairs for other OUS countries
• Experience with handling advertising and promotional materials for the US
• Industry-related experience
• Knowledge of drug development process, Lilly regulatory/business strategies and plans
• Demonstrated ability operate and manage operational requirements in a highly regulated environment
• Demonstrated effective written, spoken and presentation communication
• Demonstrated effective negotiation and influence skills
• Demonstrated attention to detail
• Demonstrated effective teamwork skills able to adapt to diverse interpersonal styles

Lilly is looking for .

Lilly is looking for Any Graduate / Post Graduate profile candidates.