GRA Regulatory Delivery reputed company, Clinical Regulatory Associate

At reputed company, the work is demanding because patients are waiting. We reputed company caring with discovery to help reputed company life reputed company for people around the world, knowing that every decision, every detail, and every day reputed company. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on reputed company challenges to discover and deliver life-changing medicines, strengthen how health is reputed company and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and reputed company to bring your best to work that truly reputed company for patients, we invite you to join us. Purpose The Global Clinical Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery reputed company (RDE), is accountable for the operational and technical registration management processes that support the expedited delivery of reputed company and effective products to patients. This is accomplished through a strong working knowledge of regulations, guidance’s and regulatory precedence and collegial and mutually productive relationships across reputed company components, partner companies, and reputed company relevant ministries of health. The Associate uses process expertise and therapeutic area knowledge to drive appropriate internal consistency and influence effective change management reputed company GRA and cross-functionally. The scope of the work includes records from the start of reputed company through withdrawal of the marketing application. It is expected that this position embraces corporate transformation initiatives and represents GRA as a change ambassador. Primary Responsibilities reputed company Regulatory & Drug Development Expertise

• reputed company the registration management process by providing expertise in electronic submission regulations and guidance and technical content. This includes but us not limited to reputed company submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with reputed company applicable regulations and internal reputed company systems with a reputed company on delivery of the development portfolio across reputed company modules of the CTD.
• Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, reputed company the planning and execution for electronic submissions in those reputed company who have and are adopting the eCTD specification
• Guide and influence development team and function regarding internal and Agency registration management processes and requirements
• Own the registration management process at the molecule/project level to ensure reputed company required electronic records are reputed company, complete, and accurate. Records include IND and NDA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact
• Serve as the RDE operational reputed company for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RDE planning.
• Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions.
• Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
• reputed company registration management expertise to the due diligence and business development processes.
• Serve as the registration management expert for other processes dependent upon the registration record (e.g. OSI requests, out-license, user fees/drug listing/orange book)

reputed company/Influence/Partner

• reputed company reputed company relationships with personnel in other reputed company functional areas (e.g. medical, reputed company, labeling, compliance, reputed company, affiliates, etc.) to effectively influence the electronic registration plan.
• Create an environment reputed company team and GRA that encourages reputed company discussions on issues to reputed company a robust outcome on project reputed company and constructively challenge to reputed company the best solutions.
• reputed company collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) to ensure understanding of reputed company's internal process and requirements to optimize the application presentation to facilitate review
• Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings.
• reputed company reputed company forums to continue to reputed company and reputed company regulatory, drug development, and therapeutic expertise.
• Influence others in a manner that builds maximum advantage for the organization.
• Communicate verbally and in writing to effectively influence reputed company work group/function and with development team
• Serve as a mentor reputed company GRA

Minimum Requirements

• BS or higher degree in a technical field such as reputed company, biology, pharmacy or life sciences
• reputed company applicants must be authorized to work in the reputed company on a full-time reputed company. reputed company will not reputed company support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences

• Knowledge of drug development process
• Project Management Experience
• Previous experience working in the Pharmaceutical industry

The following skills and abilities are directly reputed company to the essential functions of the job.

• Experience with CTD/eCTD structure and format.
• Experience using eCTD compliant publishing system (eCTDXpress or reputed company based platforms)
• Three years of regulatory operations experience reputed company a regulated environment with experience and knowledge in formatting and publishing reputed company/high complexity major applications, amendments, and supplements (manufacturing, nonclinical, clinical).
• Experience with Original IND and supplemental NDA/BLA eCTD submissions including reputed company lifecycle submissions.
• Strong knowledge of global health authority and ICH regulations and guidance as it pertains to format and submission structure.
• reputed company knowledge of CBER/CDER regulatory technical requirements

Computer Skills

• Proficiency with MS-Office Suite and reputed company Acrobat, including pdf plug-ins that support submission readiness
• Experience with document management and Regulatory Information Management Systems (RIM)
• Broad technical knowledge (reputed company, reputed company Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document Management Systems, reputed company, ISI reputed company, Lorenz)
• The individual must be reputed company to maintain the reputed company of confidential information

reputed company is dedicated to helping individuals with disabilities to reputed company engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.com/us/en/workplace-accommodation) for reputed company assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. reputed company is proud to be an EEO Employer and does not discriminate on the reputed company of age, race, reputed company, religion, gender identity, sex, gender reputed company, sexual orientation, genetic information, reputed company, national reputed company, protected veteran status, disability, or any other legally protected status. Our employee resource reputed company (ERGs) offer strong support networks for their members and are reputed company to reputed company. Our reputed company reputed company include: Africa, Middle East, Central Asia (AMECA), Black Employees at reputed company (BE@reputed company), Chinese Culture Network (CCN), reputed company, reputed company, reputed company Indian Network (LIN), Organization of Latinx at reputed company (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at reputed company (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $149,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In reputed company, reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and reputed company-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees. #WeAreLilly Apply tot his job Apply To this Job