Senior Regulatory Reporting Specialist
5 days ago
We are seeking a highly skilled and experienced Regulatory Reporting Specialist to join our team. In this role, you will be responsible for providing support across various regulatory reporting and inspection activities, including US FDA field alerts, global regulatory reporting, and support for global recall and US recall activities.
Key Responsibilities- Coordinate and execute regulatory reporting, including networking with CPQA, Global Quality Leaders, Senior Management, Legal, Global Patient Safety, Technical Services, Regulatory, Product Protection team, Lilly Security, and others as appropriate.
- Provide information for use in various periodic reviews or metrics.
- Monitor recall activities of partner organizations globally.
- Support the coordination of the execution activities related to US product recall and withdrawals.
- Participate in periodic product withdrawal/recall simulations.
- Bachelor's degree or equivalent experience in a scientific field such as Pharmacy, Chemistry, Engineering, or other biological sciences.
- Minimum of 5 plus years relevant industry experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control, or regulatory affairs.
- Previous auditing experience.
- Broad knowledge of GMPs and quality systems as they apply to pharmaceutical manufacturing and marketing.
- Significant experience with deviation management and root cause analysis.
- Experience in Quality Assurance or GxP function.
- Strong compliance knowledge.
- Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent oral and written communication and oral presentation skills.
- Ability to work independently and as part of a team with minimal supervision.
- Experience with global compliance programs.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.
-
Regulatory Compliance Specialist
1 day ago
Indianapolis, Indiana, United States Randstad Full timeWe are seeking a highly skilled Regulatory Compliance Specialist to support our client's global quality assurance policies and compliance.This is a primarily remote position, but you must be able to commute to our Indianapolis office for audits.This is a Temp To Hire opportunity.Requirements:6 years of experience in a regulatory environment, preferably in...
-
Regulatory Compliance Specialist
1 day ago
Indianapolis, Indiana, United States Randstad Full timeJob DescriptionWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at Randstad. As a key member of our quality assurance team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key Responsibilities:Conduct audits and assessments to identify areas for improvementDevelop and...
-
Senior Environmental Specialist
4 weeks ago
Indianapolis, Indiana, United States Enterprise Products Full timeJob Title: Senior Field Environmental SpecialistJob Summary:Enterprise Products is seeking a Senior Field Environmental Specialist to ensure compliance with environmental regulations and permits in the areas of Air, Water, Waste, and Emergency Response. The successful candidate will have a strong background in environmental compliance and a proven track...
-
Senior Director Global Regulatory Leads
1 day ago
Indianapolis, Indiana, United States BioSpace Full timeJob SummaryAt BioSpace, we're seeking a highly skilled Senior Director Global Regulatory Leads to join our team. As a key member of our Global Regulatory Affairs team, you will be responsible for developing and implementing innovative global regulatory strategies for our products. Your expertise will help us navigate complex regulatory environments and...
-
Senior Field Environmental Specialist
14 hours ago
Indianapolis, Indiana, United States Enterprise Products Full timeJob SummaryEnterprise Products is seeking a Senior Field Environmental Specialist to ensure compliance with environmental regulations and permits in the areas of Air, Water, Waste, and Emergency Response.Key ResponsibilitiesOversight and implementation of environmental permits and regulations.Preparation of environmental reports and compliance...
-
Regulatory Compliance Specialist
4 weeks ago
Indianapolis, Indiana, United States Guided Search Partners Full timeJob OpportunityGuided Search Partners is a trusted Executive Search firm built on the principles of trust, transparency, specialization, and long-term relationships. Our goal is to provide an exceptional experience for both clients and candidates.We specialize in delivering top-tier candidates in Food & Beverage Manufacturing to clients for their needs in...
-
Senior Quality Assurance Specialist
5 days ago
Indianapolis, Indiana, United States Lilly Full timeJob Title: Senior Quality Assurance SpecialistWe're seeking a highly skilled Senior Quality Assurance Specialist to join our team at Lilly. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.Key Responsibilities:Lead and mentor quality assurance...
-
Senior Nurse Practitioner
4 days ago
Indianapolis, Indiana, United States Rose Senior Living - Carmel Full timeJob SummaryAs a Senior Nurse Practitioner at Rose Senior Living - Carmel, you will provide direct nursing care to residents and supervise the care provided by Quality of Life Specialists. Your responsibilities will include administering medications, performing treatments and procedures, obtaining specimens as needed, and completing assessments as delegated...
-
CMC Regulatory Specialist
3 weeks ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timeJob Title: CMC Scientist with GRAAt Eurofins USA PSS Insourcing Solutions, we are seeking a highly skilled CMC Scientist with GRA to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the successful development and submission of our clients' clinical trial portfolios.Job Summary:The CMC Scientist with GRA will...
-
Regulatory Affairs Specialist
2 days ago
Indianapolis, Indiana, United States Roche Full timeAbout RocheRoche is a leading research-focused healthcare group with a presence in over 100 countries. Our mission is to push back the frontiers of healthcare and improve people's lives.The RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Roche Global Regulatory Affairs. As a key member of our team, you will be responsible...
-
Senior Analytical Technical Specialist
2 weeks ago
Indianapolis, Indiana, United States Eli Lilly Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Analytical Technical Specialist to join our Global Quality Laboratories team at Eli Lilly. As a key member of our team, you will be responsible for developing and implementing analytical methods for marketed products, ensuring compliance with regulatory expectations, and collaborating with...
-
Financial Services Regulatory Consultant
1 month ago
Indianapolis, Indiana, United States Forvis Mazars Full timeAbout Forvis MazarsForvis Mazars is a leading professional services firm that provides Advisory, Assurance, and Tax services to global clients. Our commitment to Forward Vision drives us to deliver unmatched client experiences through innovative services.Financial Services Advisory PracticeWe bring together our global footprint, clients, industry expertise,...
-
Research Regulatory Coordinator
4 days ago
Indianapolis, Indiana, United States Indiana Hemophilia & Thrombosis Center, Inc. Full timeJob Title: Research Regulatory CoordinatorAt Indiana Hematology & Thrombosis Center, Inc., we are seeking a highly skilled Research Regulatory Coordinator to join our team.Job Summary:The Research Regulatory Coordinator will be responsible for ensuring compliance with regulatory requirements and guidelines related to clinical research. This includes...
-
Financial Services Regulatory Consultant
5 days ago
Indianapolis, Indiana, United States Forvis Mazars Full timeFinancial Services Regulatory ConsultantForvis Mazars is a leading professional services firm that provides Advisory, Assurance, and Tax services. Our commitment to Forward Vision drives us to deliver unmatched client experiences through innovative services to our global clients.The Financial Services Advisory practice brings together our global footprint,...
-
Financial Services Regulatory Consultant
4 weeks ago
Indianapolis, Indiana, United States Forvis Mazars Full timeFinancial Services Regulatory ConsultantForvis Mazars is a leading professional services firm that provides Advisory, Assurance, and Tax services. Our commitment to Forward Vision drives us to deliver unmatched client experiences through innovative services to our global clients.The Financial Services Advisory practice brings together our global footprint,...
-
Senior Contract Specialist
2 weeks ago
Indianapolis, Indiana, United States Edward Jones Full timeJob Title: Senior Contract SpecialistWe are seeking a highly skilled Senior Contract Specialist to join our team at the Department of Education. As a key member of our academic programs team, you will be responsible for managing large-scale, complex contracts and ensuring their successful execution.Key Responsibilities:Define and monitor contract performance...
-
Senior Quality Control Specialist
3 weeks ago
Indianapolis, Indiana, United States Cardinal Health Full timeJob SummaryWe are seeking a highly skilled Senior Specialist, Quality Control Chemist II to join our team at Cardinal Health. This role will be responsible for ensuring the quality and compliance of our products and services.Key ResponsibilitiesDevelop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards...
-
Senior Quality Assurance Specialist
3 weeks ago
Indianapolis, Indiana, United States INCOG BioPharma Services Full timeSenior Quality Assurance SpecialistINCOG BioPharma Services is seeking a highly skilled Senior Quality Assurance Specialist to join our team in Indianapolis, IN. As a key member of our Technical Operations team, you will be responsible for ensuring the quality and integrity of our products.Key Responsibilities:Review and approve documentation for Quality...
-
Senior Quality Assurance Specialist
3 weeks ago
Indianapolis, Indiana, United States Harba Solutions Inc. Full timeJob Title: Senior Quality EngineerAt Harba Solutions Inc., we are seeking a highly skilled Senior Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our products and processes.Responsibilities:Analyze process and product performance data to identify areas...
-
Nurse Care Specialist
2 days ago
Indianapolis, Indiana, United States American Senior Communities Full timeUnlock a rewarding career as a Nurse Care Specialist at American Senior Communities, where you'll have the opportunity to make a meaningful impact on the lives of our residents. As a key member of our team, you'll utilize your advanced nursing skills to provide top-notch medical attention and foster a nurturing environment.Responsibilities:Deliver...