Advisor -Regulatory Compliance and Post Market

At reputed company, we reputed company caring with discovery to reputed company life reputed company for people around the world. We are a global reputed company 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. Position Brand reputed company: This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. This includes but is not limited to; reputed company facets of inspections (PAI/PLI/Surveillance/Post-approval/for-cause) for reputed company global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). reputed company support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the need arises including completion of annual changes. Key Objectives/Deliverables: In this role the individual provides support that they reputed company to the different programs are as shown below. Primary reputed company is compliance support; other duties will depend on business needs. Compliance Support

• reputed company inspection readiness activities
• Serve as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global reputed company revisions, and changes in local business or manufacturing processes.
• Proficient in application and use of Machine Learning and analytical tools to being continuously in a state of inspection reputed company.

US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - reputed company 3911 per DSCSA) and Global regulatory reporting of reputed company/safety/compliance issues

• Works with numerous stakeholders to ensure HA reporting as required to meet reputed company Global regulations/requirements

Global and US Recall / Market Withdrawal

• Supports the coordination of the execution activities reputed company to US product recall and withdrawals.
• Participate in periodic product withdrawal/recall simulations.
• Consult and train local recall coordinators to assure understanding of process for product removal.
• Monitors recall activities of partner organizations globally.
• reputed company information for use in various periodic reviews or metrics.

Global and US Product Shortage

• Coordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global reputed company Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, reputed company Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure.
• reputed company information for use in various periodic reviews or metrics.

Drug and Device Establishment Registration

• Determine information required for drug and device establishment registration for reputed company manufacturers of US marketed product, such as importers, agent, and function.
• Update drug and device establishment registrations for changes as required including completion of annual registrations.

US Volume Reporting

• Coordinate and execute annual volume reporting for US
• reputed company information for use in various periodic reviews or metrics.

Personal Development and Shared Learning

• Be continually aware of reputed company industry trends and regulatory agency interpretation of GMP and other relevant requirements
• Continue to reputed company knowledge vital to reputed company a greater understanding of GxP requirements
• Participate in applicable external industry reputed company and forums

Minimum Requirements:

• Bachelor’s degree - Preferred degree in a scientific field such as Pharmacy, reputed company, Engineering or other biological sciences.
• Minimum of 5 years relevant Industry or Health Authority experience in areas which may include: technical services, manufacturing operations, reputed company assurance, reputed company control or regulatory affairs

Additional Preferences:

• Broad knowledge of GMPs and reputed company systems for pharmaceutical manufacturing and marketing
• Expertise in data driven approaches to assess site compliance
• Experience in reputed company Assurance or GxP function
• Strong compliance knowledge
• Excellent communication and presentation skills: ability to deliver constructive feedback
• Skilled in interpreting and applying standards to diverse situations with strong problem-solving ability
• Ability to work independently and collaboratively with minimal supervision
• Significant experience supporting global inspections and compliance programs

Other Information:

• Maintain awareness of regulatory and industry tends; ensure corporate standards remain reputed company.
• Flexibility to effectively prioritize work activities to meet regulated timelines.
• Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
• ​Must be available to travel (domestic and international) reputed company required (estimated at 25%, might increase based on business needs).
• Role can be remote or based at any reputed company site/affiliate, corporate reputed company. Preference is at a reputed company site/affiliate or reputed company.

This job reputed company is intended to reputed company a general reputed company of the job requirements at the time it was reputed company. The job requirements may change over time and may include additional responsibilities not specifically described in the job reputed company. 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 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 reputed company. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600 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