Lilly Manager in Branchburg, New Jersey
It is an exciting time to join Lilly. Are you looking for a role in Global Regulatory CMC where you can lead development of submissions for biotechnology products? This exciting opportunity is for someone with CMC regulatory submission experience to make a real impact on human health. You will have the chance to grow and learn while working with exceptional scientists. We are looking for a Biotech CMC Regulatory Scientist to join our team. Your role would be to develop and execute global regulatory CMC submission plans for assigned biologic development projects and/or marketed products. You will partner with scientists to lead all aspects of CMC submissions including BLAs and supplements.
In this role you are responsible for preparing accurate, clear and concise regulatory documents; and for providing knowledgeable input to interdisciplinary project teams and management. You assess current/emerging regulations, guidance documents and corporate/industry standards for impact to the business area. You collaborate effectively with partners across project teams, third party vendors and/or development partners to ensure effective project communication and coordination for submission assignments and special projects.
Some primary responsibilities could include:
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.
Lead cross functional Health Authority response teams for assigned projects to set objectives for HA meetings, lead interactions and oversee preparation responses.
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.
Ability to handle tasks and projects independently.
Broad knowledge of global biotech CMC guidances and regulations.
Broad technical foundation and a deep understanding of biologics or other pharmaceutical product development, and experience in the preparation of CMC dossiers.
Excellent interpersonal skills and ability to establish and maintain relationships with various intra-department, inter-department, and external third party personnel.
Detail-attentive and dedicated with a focus on transparency, accuracy and conciseness.
Able to prioritize and manage time effectively.
Experience in the preparation of US/EU marketing applications and supplements.
Experience in investigational and rest-of-world filings strongly preferred.
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.
CMC Regulatory Scientist
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.
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.
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