BioSpace
Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Mo
BioSpace, Indianapolis, Indiana, us, 46262
Overview Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Molecules
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. Join to apply for the Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Molecules role at BioSpace. 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 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. At Eli Lilly, we create medicines that give people new hope – to get better, feel better, live better. It’s our purpose to create medicines that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world. Responsibilities
Leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning. Lead preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions. Take a proactive leadership role in the critical review of molecule-specific CMC development strategies and submission content. Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members. Basic Qualifications/Requirements
B.S. degree in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar. Minimum of five years of Regulatory CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than five years experience are encouraged to apply. Additional Skills/Preferences
Experience authoring CMC submission content, and involvement in CTA/MAA processes including response to questions. Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives desirable. Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing. Demonstrated deep knowledge of the synthetic molecule drug development process. Knowledge in new molecular modalities (e.g., oligonucleotides, synthetic peptides) or new manufacturing technologies (e.g., continuous manufacturing) preferred but not required. Experience planning for and participating in Health Authority meetings. Demonstrated ability to assess and manage risk in a highly regulated environment. Demonstrated strong written, spoken and presentation communication skills. Demonstrated leadership behaviors and negotiation and influence skills. Demonstrated attention to detail. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles. Additional Information
Position Location: Indianapolis, IN. This is not a remote position. Relocation assistance is provided. Travel: minimal within the US Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $211,200. Full-time equivalent employees also will be eligible for a company bonus and a comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision, flexible spending accounts, life insurance, time off, and well-being benefits.
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Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. Join to apply for the Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Molecules role at BioSpace. 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 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. At Eli Lilly, we create medicines that give people new hope – to get better, feel better, live better. It’s our purpose to create medicines that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world. Responsibilities
Leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning. Lead preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions. Take a proactive leadership role in the critical review of molecule-specific CMC development strategies and submission content. Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members. Basic Qualifications/Requirements
B.S. degree in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar. Minimum of five years of Regulatory CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than five years experience are encouraged to apply. Additional Skills/Preferences
Experience authoring CMC submission content, and involvement in CTA/MAA processes including response to questions. Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives desirable. Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing. Demonstrated deep knowledge of the synthetic molecule drug development process. Knowledge in new molecular modalities (e.g., oligonucleotides, synthetic peptides) or new manufacturing technologies (e.g., continuous manufacturing) preferred but not required. Experience planning for and participating in Health Authority meetings. Demonstrated ability to assess and manage risk in a highly regulated environment. Demonstrated strong written, spoken and presentation communication skills. Demonstrated leadership behaviors and negotiation and influence skills. Demonstrated attention to detail. Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles. Additional Information
Position Location: Indianapolis, IN. This is not a remote position. Relocation assistance is provided. Travel: minimal within the US Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $211,200. Full-time equivalent employees also will be eligible for a company bonus and a comprehensive benefits program including 401(k), pension, vacation, medical/dental/vision, flexible spending accounts, life insurance, time off, and well-being benefits.
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