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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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for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ... them all over the world.
We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part
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Lilly
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Indianapolis, Indiana
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for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ... them all over the world.
We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part
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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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Indianapolis, Indiana
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immunology
Provide media training, communications counsel and mentoring for internal business partners ... and providing appropriate communications counsel and support to senior leaders
Experience
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Lilly
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Indianapolis, Indiana
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immunology
Provide media training, communications counsel and mentoring for internal business partners ... and providing appropriate communications counsel and support to senior leaders
Experience
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Lilly
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Indianapolis, Indiana
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Solid regulatory compliance knowledge (GMP, OSHA, etc.)
Understanding of equipment reliability
Additional Preferences:
Previous supervisory/leadership experience
Experience with regulatory
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Lilly
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Indianapolis, Indiana
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better for people around the world.
Purpose:
The Global Regulatory Affairs Product Owner ... within the Veeva Vault Regulatory Information (RIM) system or related technologies. The role will
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Lilly
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Indianapolis, Indiana
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updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies ... decision or regulatory submission.
Support preparation of high-level plan for phase 1, 2 and 3 studies
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Lilly
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Indianapolis, Indiana
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better for people around the world.
Purpose
The Global Regulatory Affairs (GRA) Labeling ... assigned country/region. The Global Regulatory Affairs (GRA) Labeling Implementation develops collegial
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Lilly
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Indianapolis, Indiana
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investigations. They participate in regulatory inspections and collaborate in the PR&D inspection readiness ... regulatory expectations, industry best practices with regards to the deviation, non-conformities, and
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Lilly
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Indianapolis, Indiana
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, including architecture, regulatory compliance, and security protocols.
Increase the adoption and
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Lilly
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Indianapolis, Indiana
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framework aligns with industry best practices, regulatory requirements, and organizational objectives. The ... organization’s overall cybersecurity GRC goals, ensuring alignment with regulatory and corporate governance
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Lilly
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Indianapolis, Indiana
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laboratories, stability, materials, data stewardship, complaints, regulatory interactions, inspection readiness ... others in support of regulatory inspections
Provide guidance to significant investigations and
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Lilly
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Indianapolis, Indiana
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Regulatory partners to ensure content and functionality are compliant and meet any relevant regulatory ... regulatory requirements (e.g., GDPR and CCPA).
Demonstrated and successful history leading large-scale
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Lilly
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Indianapolis, Indiana
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regulatory compliance, consistency, and maintenance. The Sr. Principal Lab Data Integrity and CSQA will also ... computer systems and analytical instrument current regulatory and industry expectations.
Ensure PR
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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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Indianapolis, Indiana
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in this role will possess detailed knowledge of global regulatory requirements and have a practical ... key contact for technical and regulatory inquiries generated by business areas, auditors, and
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Lilly
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Indianapolis, Indiana
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, state regulatory agencies, and local elected officials.
Develop and maintain relationships with ... knowledge of the legislative and regulatory process in multiple geographies
Qualified candidates must
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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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provide support during internal / external regulatory inspections.
Effectively review / approve GMP
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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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-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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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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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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strategies, implementing Data governance and standards.
Understanding of regulatory 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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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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