At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 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 make life better for people around the world.
Post : Regulatory Scientist
Responsibilities
• Represent Regulatory CMC on interdisciplinary teams and technical project teams to outline submission requirements, negotiate timelines for delivery of regulatory CMC submissions.
• Collaborate with multi-disciplinary teams, prepare the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions.
• Lead cross functional Health Authority response teams for assigned development projects to set objectives for HA meetings, lead interactions and oversee preparation of HA responses.
• Drive quality control of business function components within assigned role to meet timelines and to provide quality deliverables.
• Review and assess the regulatory impact of change controls/requests for the manufacture, testing and release of development and marketed products in collaboration with internal departments (Research, Manufacturing and Product Development and QA/QC) and external business partners.
• Provide regulatory guidance to ensure development activities are aligned with relevant health authority regulations and in line with current global guidance.
• Assist in preparation of risk analyses and contingency plans for CMC regulatory strategies and dossiers.
• Guide manufacturing in developing data for approval of post-marketing changes.
• Understand and apply regulatory CMC requirements, FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive).
Candidate Profile
• Bachelor Degree
• At least 4 years of pharmaceutical industry experience, with a minimum of 2 years of global regulatory submissions experience.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Information :
Experience : 4 years
Qualification : Bachelor Degree
Location : New Jersey
Industry Type : Pharma
Functional Area : Market Access
End Date : 24-Aug-2018
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