CMC Regulatory Scientist
5 days ago
At 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 team, you will play a critical role in providing strategic, tactical, and operational direction and support to expedite the development of our client's clinical trial portfolio.
Key Responsibilities:- Lead the preparation, technical and regulatory review, and finalization of CMC sections for global CTA submissions and respond to questions.
- Take a proactive leadership role in the critical review of molecule-specific GRA-CMC development strategies and submission content.
- Make technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.
- Network and gain alignment with CMC team members and GRA-CMC regulatory scientists to resolve complex issues.
- Assist in the development of regulatory strategy and update strategy based upon global regulatory changes.
- Provide high-quality, timely, and clear regulatory advice to allow CMC teams to make well-informed decisions.
- Evaluate regulatory impact on proposed CMC development plans.
- Anticipate and resolve key technical or operational issues that can impact the function or CMC team.
- Participate in risk-benefit analysis for regulatory compliance.
- Develop relationships with GRA-CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.
- Communicate effectively verbally and in writing to influence within GRA-CMC and with CMC development team.
- Demonstrate negotiation and influence skills. Demonstrate effective teamwork skills, able to adapt to diverse interpersonal styles.
- Proactively identify and resolve global CMC regulatory issues.
- Partner with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies.
- Partner with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.
- Five or more years of global regulatory CMC experience, or equivalent experience supporting CMC functions contributing to clinical trial phases of development in various regions, including US, EU, and Asia. Or 5 years' experience in large molecule/biologics research and development or formulation.
We offer a competitive salary and benefits package, including comprehensive medical coverage, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays, and more. If you are a motivated and experienced CMC Scientist with GRA looking for a new challenge, please submit your application.
-
CMC Regulatory Scientist
3 weeks ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timeJob Title: CMC Regulatory ScientistJoin Eurofins USA PSS Insourcing Solutions as a CMC Regulatory Scientist and play a key role in expediting the development of our client's clinical trial portfolio. As a member of our team, you will provide strategic, tactical, and operational direction to support the development of successful regulatory strategies and...
-
Scientist - CMC Regulatory Expert
12 hours ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timeJob Title: Scientist - CMC Regulatory ExpertAt Eurofins USA PSS Insourcing Solutions, we are seeking a highly skilled Scientist - CMC Regulatory Expert to join our team. As a key member of our regulatory team, you will be responsible for providing strategic, tactical, and operational direction and support to expedite the development of our client's clinical...
-
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...
-
CMC Scientist with GRA
3 weeks ago
Indianapolis, Indiana, United States Eurofins Lancaster Laboratories Professional Scientific Services, LLC Full timeJob DescriptionPosition Overview:This position will provide strategic, tactical, and operational direction and support to expedite development of our client's clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials.In order to meet client expectations, it is necessary for our entire PSS...
-
CMC Regulatory Strategist
3 days ago
Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full timeJob OverviewEurofins USA PSS Insourcing Solutions is seeking a highly skilled CMC Regulatory Strategist to join our team. As a key member of our regulatory team, you will play a critical role in developing and implementing regulatory strategies to support the development of our clients' clinical trial portfolios.This is an exciting opportunity to work with a...
-
Senior Director Global Regulatory Leads
14 hours 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...
-
Veterinary Research Scientist
3 weeks ago
Indianapolis, Indiana, United States RPM ReSearch Full timeJob SummaryWe are seeking a highly skilled and experienced Veterinary Research Scientist to join our team at RPM ReSearch. As a Clinical Laboratory Animal Veterinarian and Assistant Director, you will be responsible for providing veterinary care and services to laboratory animals, ensuring compliance with regulatory requirements, and providing leadership...
-
Senior Research Scientist
2 months ago
Indianapolis, Indiana, United States Lilly Full timeJob Summary:We are seeking a highly skilled and experienced Senior Research Scientist 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 in our products and processes.Key Responsibilities:Provide daily oversight and guidance on quality-related issues to ensure...
-
Environmental Scientist Leader
3 weeks ago
Indianapolis, Indiana, United States T&M Associates Full timeJob OpportunityT&M Associates is seeking a highly experienced Supervising Environmental Scientist to join our team in Columbus, Ohio. The ideal candidate will have a strong background in Federal/State RCRA programs and regulations, with a minimum of 15 years of experience in a consulting role.Key Responsibilities:Provide expert guidance on RCRA permitting,...
-
Scientist - Biotransformation Specialist
4 weeks ago
Indianapolis, Indiana, United States IQVIA Full timeWe are seeking a highly skilled Scientist - Biotransformation Specialist to join our team at IQVIA.As a key member of our laboratory team, you will be responsible for conducting and documenting analytical procedures, contributing to the design and execution of bioanalytical methods, and ensuring compliance with regulatory guidelines.Key...
-
Medical Laboratory Scientist II
3 weeks ago
Indianapolis, Indiana, United States MassGenics Full timeJob Title: Medical Laboratory Scientist IIJob Summary: Innova Solutions is seeking a highly skilled Medical Laboratory Scientist II to join our team. As a Medical Laboratory Scientist II, you will be responsible for performing routine and complex technical procedures and functions according to departmental Standard Operating Procedures. You will also be...
-
Indianapolis, Indiana, United States IQVIA Full timeJob Summary: As a Scientist in Biotransformation for Large Molecules, you will be instrumental in conducting and documenting analytical procedures, contributing to the design and execution of bioanalytical methods, and ensuring compliance with regulatory guidelines.Key Responsibilities:Perform and document analytical procedures in line with company and...
-
Indianapolis, Indiana, United States Corteva Agriscience Full timeAbout the OpportunityCorteva Agriscience is seeking highly motivated and talented students to join our Crop Health and Regulatory Sciences Research and Development organization as interns. This is a unique opportunity to collaborate closely with senior scientists in an industrial setting and network extensively across the company.Key ResponsibilitiesEngage...
-
Indianapolis, Indiana, United States Corteva Agriscience Full timeJob Opportunity at Corteva AgriscienceCorteva Agriscience is seeking highly motivated and talented students for full-time internships within our research and development organization in either Indianapolis, Indiana or Newark, Delaware.As a Regulatory Sciences R&D Intern, you will have the opportunity to work closely with a senior scientist in an industrial...
-
Indianapolis, Indiana, United States Corteva Full timeResearch and Development Internship in Regulatory SciencesCorteva Agriscience is seeking students for full-time internships within our research and development organization in either Indianapolis, Indiana or Newark, Delaware. Our company offers students the opportunity to work closely with a senior scientist in an industrial setting, and the students will...
-
Indianapolis, Indiana, United States Corteva Agriscience Full timeGrow Your Future with Corteva AgriscienceCorteva Agriscience is excited to offer full-time internships within our Crop Health and Regulatory Sciences Research and Development organizations in Indianapolis, Indiana.Why Choose This Internship?Hands-On Experience: Work on real-world projects and gain practical experience in a research environment.Mentorship:...
-
Indianapolis, Indiana, United States Corteva Full timeGrow Your Future with CortevaCorteva Agriscience is excited to offer full-time internships within our Crop Health and Regulatory Sciences Research and Development organizations in Indianapolis, Indiana.Why Choose This Opportunity?Hands-On Experience: Work on real-world projects and gain practical experience in a research environment.Mentorship: Receive...
-
Data Scientist Clinical Trial Design
4 days ago
Indianapolis, Indiana, United States Pharmavise Corporation Full timeJob Title: Data Scientist Clinical Trial DesignJob Summary:The Data Scientist Clinical Trial Design will bring together internal and external data and information, analyses, insights, and metrics, to drive excellence in program/trial design and delivery, enabling more efficient planning and execution to speed medicines to patients.Responsibilities:•...
-
Regulatory Sciences R&D Internship Opportunity
3 weeks ago
Indianapolis, Indiana, United States Corteva Full timeJoin Our Research and Development TeamCorteva Agriscience is seeking highly motivated students for full-time internships within our research and development organization in either Indianapolis, Indiana or Newark, Delaware.As a Regulatory Sciences R&D Intern, you will have the opportunity to work closely with a senior scientist in an industrial setting, and...
-
Indianapolis, Indiana, United States Corteva Full timeJoin Our Research TeamCorteva Agriscience is seeking highly motivated students for full-time internships within our research and development organization in either Indianapolis, Indiana or Newark, Delaware.As a research intern, you will have the opportunity to work closely with a senior scientist in an industrial setting, and you will have extensive...
