BioSpace
Senior Advisor/Director Global Regulatory Affairs CMC – Commercial Product/Post
BioSpace, Indianapolis, Indiana, us, 46262
Senior Advisor/Director Global Regulatory Affairs CMC – Commercial Product/Post Approval Scientist
Base pay range: $144,000.00/yr - $211,200.00/yr
At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We discover and bring medicines to patients, improve understanding and management of disease, and engage in philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world.
Lilly is seeking post-approval regulatory CMC scientists to join Global Regulatory Affairs – CMC for commercial solid oral products to deliver life-changing medicines to patients worldwide. The Senior Advisor/Director, Post-approval Scientist will use CMC technical knowledge and regulatory science to drive regulatory CMC strategies and lifecycle submissions. The role encourages innovative regulatory strategies that support the lifecycle of the assigned product(s).
Responsibilities
Deep technical knowledge of solid oral products CMC science and manufacturing processes.
Knowledge of global CMC regulatory requirements and guidelines for reporting post-approval changes and updating global product registrations.
Develop and evaluate global CMC regulatory strategies with regulatory, manufacturing, quality and project teams to enable timely submission milestones leading to health authority approval.
Develop regulatory strategies and update strategies based on global regulatory changes.
Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and lifecycle planning.
Anticipate and resolve technical or operational issues that could impact function, CMC team, or submission timing.
Independently manage challenging projects and identify creative solutions to support functional and partner requirements.
Lead critical reviews of molecule-specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions.
Make decisions on CMC regulatory strategies impacting submissions across geographies and networks for alignment with CMC team members.
Engage in site-specific regulatory activities to maintain registered commitments at responsible manufacturing sites.
Basic Qualifications/Requirements
B.S. degree in a science, engineering, or related field (advanced degree preferred). Fields may include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
5+ years of Regulatory CMC experience and/or equivalent (such as supporting CMC functions for commercialization of solid oral products with regulatory submission experience). Those with greater than five years are encouraged to apply.
Additional Skills/Preferences
Deep technical knowledge of small molecule drug product development, commercialization and manufacturing processes.
Regulatory CMC experience supporting commercialization and/or post-approval submissions for small molecule products, or equivalent combination of technical and regulatory guidance.
Knowledge of major market procedures, regulations, and practices.
Awareness of evolving global regulatory initiatives.
Experience planning for and/or participating in Health Authority meetings.
Ability to assess and manage risk in a highly regulated environment.
Strong written, spoken and presentation communication skills.
Demonstrated leadership, negotiation and influence skills; attention to detail; effective teamwork.
Additional Information
Position Location: Indianapolis, IN. Remote option not available.
Travel: minimal within the US.
Equal Employment Opportunity Lilly is dedicated to helping individuals with disabilities to participate in the workforce. If accommodation is needed to submit a resume, please complete the accommodation request form. Lilly is proud to be an EEO Employer and does not discriminate on protected characteristics.
Actual compensation will depend on education, experience, and location. The anticipated wage for this position is $144,000 - $211,200. Full-time employees are eligible for a company bonus and a comprehensive benefits package.
#WeAreLilly
#J-18808-Ljbffr
At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We discover and bring medicines to patients, improve understanding and management of disease, and engage in philanthropy and volunteerism. We’re looking for people who are determined to make life better for people around the world.
Lilly is seeking post-approval regulatory CMC scientists to join Global Regulatory Affairs – CMC for commercial solid oral products to deliver life-changing medicines to patients worldwide. The Senior Advisor/Director, Post-approval Scientist will use CMC technical knowledge and regulatory science to drive regulatory CMC strategies and lifecycle submissions. The role encourages innovative regulatory strategies that support the lifecycle of the assigned product(s).
Responsibilities
Deep technical knowledge of solid oral products CMC science and manufacturing processes.
Knowledge of global CMC regulatory requirements and guidelines for reporting post-approval changes and updating global product registrations.
Develop and evaluate global CMC regulatory strategies with regulatory, manufacturing, quality and project teams to enable timely submission milestones leading to health authority approval.
Develop regulatory strategies and update strategies based on global regulatory changes.
Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and lifecycle planning.
Anticipate and resolve technical or operational issues that could impact function, CMC team, or submission timing.
Independently manage challenging projects and identify creative solutions to support functional and partner requirements.
Lead critical reviews of molecule-specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions.
Make decisions on CMC regulatory strategies impacting submissions across geographies and networks for alignment with CMC team members.
Engage in site-specific regulatory activities to maintain registered commitments at responsible manufacturing sites.
Basic Qualifications/Requirements
B.S. degree in a science, engineering, or related field (advanced degree preferred). Fields may include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
5+ years of Regulatory CMC experience and/or equivalent (such as supporting CMC functions for commercialization of solid oral products with regulatory submission experience). Those with greater than five years are encouraged to apply.
Additional Skills/Preferences
Deep technical knowledge of small molecule drug product development, commercialization and manufacturing processes.
Regulatory CMC experience supporting commercialization and/or post-approval submissions for small molecule products, or equivalent combination of technical and regulatory guidance.
Knowledge of major market procedures, regulations, and practices.
Awareness of evolving global regulatory initiatives.
Experience planning for and/or participating in Health Authority meetings.
Ability to assess and manage risk in a highly regulated environment.
Strong written, spoken and presentation communication skills.
Demonstrated leadership, negotiation and influence skills; attention to detail; effective teamwork.
Additional Information
Position Location: Indianapolis, IN. Remote option not available.
Travel: minimal within the US.
Equal Employment Opportunity Lilly is dedicated to helping individuals with disabilities to participate in the workforce. If accommodation is needed to submit a resume, please complete the accommodation request form. Lilly is proud to be an EEO Employer and does not discriminate on protected characteristics.
Actual compensation will depend on education, experience, and location. The anticipated wage for this position is $144,000 - $211,200. Full-time employees are eligible for a company bonus and a comprehensive benefits package.
#WeAreLilly
#J-18808-Ljbffr