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Lilly
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Indianapolis, Indiana
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better for people around the world.
We are seeking an Advisor/Senior Advisor for Global Regulatory Affairs CMC to be a part of the Lilly Global Regulatory Group to support global submissions and
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Lilly
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Indianapolis, Indiana
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reports to the Associate Vice President and Assistant General Patent Counsel Cardio-metabolic Health and
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Lilly
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Indianapolis, Indiana
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Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the
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Lilly
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Remote, Indiana
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help shape regulatory strategies on the utilization of RWD for purposes of registration where ... assessment and reimbursement globally and other regulatory RWE use.
Technical leadership in statistical
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Lilly
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Indianapolis, Indiana
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practices.
Review and approve PK/PD global regulatory submissions and responses, Tox/Drug Disposition ... , Regulatory Affairs and Therapeutic Area scientists.
Minimum requirements:
PhD degree in
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Lilly
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Lebanon, Indiana
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, Validation, Development, and Regulatory departments. Interaction may be required with other Lilly site ... pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role
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Lilly
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Lebanon, Indiana
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various regulatory agencies.
Responsibilities:
**Provide Process & Equipment Support ... and/or lead self-inspection activities
Participate in and/or support regulatory inspections and
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Lilly
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Indianapolis, Indiana
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trials, product commercialization, and regulatory submissions. The position presents an opportunity to ... networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement
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Lilly
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Indianapolis, Indiana
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regulatory requirements and commitments.
Conduct usability testing as required
Facilitate the
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Lilly
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Indianapolis, Indiana
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support during
preparation for Pre-Approval / General Inspections by various regulatory agencies ... / external regulatory
inspections
• Ability to effectively review and / or redline documents to ensure
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Lilly
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Indianapolis, Indiana
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Provide support during internal / external regulatory inspections.
Participates in Lean project or ... Regulatory is desirable.
Technical Writing and Communication Skills
Demonstrated ability to work
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Lilly
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Lebanon, Indiana
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according to enterprise policies and regulatory requirements.
This role will collaborate within the ... readiness for regulatory authority inspections at the Lilly Lebanon site and if required, effectively
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Lilly
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Lebanon, Indiana
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control, development, and regulatory departments. Interaction maybe required with other Lilly site ... pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role
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Lilly
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Indianapolis, Indiana
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-evolving regulatory landscape. This position offers a unique opportunity to lead, learn, and make a ... local, regional, and global regulatory requirements for laboratory and diagnostic.
Influences
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Lilly
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Indianapolis, Indiana
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responsible for providing support across the different regulatory reporting and inspection support that is ... , US FDA field alert, biological product, illegitimate product, global regulatory reporting, support
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Lilly
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Lebanon, Indiana
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all regulatory requirements at all times.
Support the execution of the production plan for the ... accordance with local and corporate regulatory requirements.
Enter Trackwise events, participate in and
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Lilly
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Lebanon, Indiana
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, Procurement, Regulatory departments, other Lilly sites and external suppliers. Knowledge of chemistry and ... manufacturing.
An understanding of cGMP and regulatory requirements.
Lilly is dedicated to helping
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Lilly
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Indianapolis, Indiana
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practices in an effective and efficient manner. We combine high quality counsel with decades of practical ... expertise, counsel/mentorship, and daily support for the following program areas: Exposure Assessment and
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Lilly
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Lebanon, Indiana
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performance to senior management and promote awareness of applicable regulatory requirements through ... execution of key site quality programs; regulatory submissions; process oversight/batch release; and site
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Lilly
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Indianapolis, Indiana
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including Chemistry, Discovery Biology, Drug Disposition, Pathology, Medical/Clinical, and Regulatory ... research and/or regulatory environment.
Contribute to a group of highly engaged scientists, providing
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Lilly
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Indianapolis, Indiana
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, Pathology, Medical/Clinical, and Regulatory Affairs within Lilly and with external research organizations ... both internally within Lilly and in the external research and/or regulatory environment
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Lilly
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Indianapolis, Indiana
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responsible for providing support across the different regulatory reporting and inspection support that is ... product, illegitimate product, global regulatory reporting, support for global recall and US recall
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Lilly
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Indianapolis, Indiana
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evaluation of safety data for global regulatory purposes:
Represent the therapeutic area and/or ... Patient Safety expertise to internal customers (e.g., regulatory, discovery and clinical research
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Lilly
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Indianapolis, Indiana
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Manufacturing (IDM), Regulatory, and others throughout the commercialization process.
**Key Objectives ... , regulatory submissions, deviation investigations, stability strategies, validations, procedures
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Lilly
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Indianapolis, Indiana
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change management processes, and understanding of regulatory requirements.
Manage People Effectively
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Lilly
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Indianapolis, Indiana
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regulatory agencies.
Responsibilities:
Responsible for adhering to safety rules and ... provide support during internal / external regulatory inspections
Ability to effectively review and
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Lilly
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Lebanon, Indiana
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contractors comply with all HSE regulatory commitments and SOP’s.
**Basic Requirements
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Lilly
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Indianapolis, Indiana
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with regulatory function to align on regulatory strategies for new products, packaging, platform ... science, manufacturing technology, regulatory and compliance environment. Leverage these to improve
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Lilly
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Plainfield, Indiana
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operations are conducted in a high quality, regulatory-compliant manner; for maintaining the security of ... understanding of the pharmaceutical industry and distribution, warehousing, regulatory, and sales practices
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Lilly
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Indianapolis, Indiana
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requirements and supports CMC and Regulatory timelines
Responsible for Tech Transfer Plans/Reports and
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