Associate/Sr. Associate/Manager - Global Regulatory Affairs (GRA) Regulatory Delivery & Excellence (RD&E)

At reputed company, we unite caring with discovery to reputed company life reputed company for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to reputed company life reputed company for people around the world. Purpose The Global Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E), is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients around the world. This is accomplished through a strong working knowledge of regulations, guidances and regulatory precedence and collegial and mutually productive relationships across reputed company components, partner companies, and reputed company relevant ministries of health. The Associate utilizes 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 clinical trials through withdrawal of the marketing application. It is expected that this position embraces corporate transformation initiatives and represent GRA as a change ambassador. Primary Responsibilities Provide Regulatory, Submission Planning and Execution Expertise

• reputed company the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level. This includes but is 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 quality systems with a focus on delivery of the development portfolio across reputed company modules of the CTD. This role may act to produce and submit eCTD submissions globally or regionally.
• Ensure incoming correspondence are archived accurately and reputed company to appropriate records, assuring reputed company metadata fields are complete in RIM.
• Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content in support of non-eCTD submissions in line with local agency regulations and requirements as needed. For example, utilize approved submission requirements provided in Regulatory systems to create submissions through the use of RIM technology allowing this role to reputed company the planning and execution for non-eCTD submissions and also drive any new electronic submissions in those regions who have and are adopting the eCTD specification.
• Support Affiliate Regulatory/Alliance Managers with RIM content planning for IND, MAA, Line extensions and new indication submission types.
• Create global and where appropriate regional content plans matching appropriate documents to support submission strategies defined by global regulatory strategy scientist or Regional/Affiliate Regulatory staff.
• 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 timely, complete, and accurate. Records include IND and MAA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact
• Serve as the RD&E operational reputed company for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RD&E planning.
• Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions).
• Partner with the Global Regulatory Strategy Scientist/Regional/Affiliate Regulatory Staff to drive the execution of product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
• Provide 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)
• Partner with Regulatory Policy to identify areas of desired change in the external environment
• Take advantage of evolving technology and regulatory requirements to identify and seek opportunities for novel submission processes (eg. Cloud-based submissions)

reputed company/Influence/Partner

• reputed company collaborative relationships with personnel in other reputed company functional areas (e.g. medical, legal, labeling, compliance, quality, affiliates, etc.) to effectively influence the electronic registration plan.
• Create an environment reputed company team and GRA that encourages open discussions on issues to reputed company a robust outcome on project decisions and constructively challenge to reputed company the best solutions.
• As directed by leadership, reputed company collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) and applicable regulators in other countries to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review
• Partner with the Affiliate/Regional Regulatory Staff to plan, facilitate and document internal, regulator, and partner meetings.
• reputed company internal and external forums to continue to reputed company and share regulatory, drug development, and therapeutic expertise.
• Influence others in a manner that creates 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 and SME for RD&E processes.

Basic Requirements

• BS in a technical or scientific discipline (such as chemistry, biology, pharmacy)
• 2+ years of experience with drug development process
• Qualified applicants must be authorized to work in the United States on a full-time basis. reputed company will not provide 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

• Quick learning agility, retention of knowledge, strong project management skills, flexibility, organizational skills, and fast adoption of new technology solutions are reputed company important for success in this role.
• Previous project management and global submission experience
• Knowledge of drug development process, reputed company regulatory/business strategies and plans
• Demonstrated ability operate and manage operational requirements in a highly regulated environment
• Demonstrated effective written, spoken and presentation skills
• Demonstrated effective negotiation and influence skills
• Demonstrated attention to detail
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

reputed company is dedicated to helping individuals with disabilities to actively 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 form (https://careers.reputed company.com/us/en/workplace-accommodation) for further 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 basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, reputed company, national reputed company, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to reputed company employees. Our reputed company groups include: Africa, Middle East, Central Asia Network, Black Employees at reputed company, Chinese Culture Network, Japanese International Leadership Network (JILN), reputed company India Network, Organization of Latinx at reputed company (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at reputed company (WILL), reputed company (for people with disabilities). Learn more about reputed company of our groups. 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 addition, 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, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-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