Associate/Manager â CMC Regulatory
Found in: beBee S US - 2 weeks ago
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. Weâre looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Overview:
The Associate/Manager â CMC Regulatory is responsible for the preparation and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.
Responsibilities:
Responsible for the generation and execution of country specific CMC regulatory strategiesAuthor and review global CMC dossiersCoordinate and contribute to responses to regulatory agency questionsParticipate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plansMaintain submission information according to the Regulatory Information Management (RIM) system.Support CMC regulatory assessment for change controlsKeep current with global regulatory guidelines applicable to CMCPerform other duties as assigned.Basic Qualifications:
Bachelorâs degree in chemistry, biochemistry, or related field, or advanced degree such as PharmD2 Years experience in pharmaceutical development and/or manufacturing with CMC regulatory experience or related (e.g. CMC writer, lab 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 positionAdditional Skills/Preferences:
Excellent technical writing skillsStrong communication skills with ability to work within global multi-disciplinary teamsAbility to plan, prioritize and handle multiple tasks concurrentlyAbility to independently complete assigned workload with minimum supervisionAbility to adapt to change and work in a fast-paced environmentOrganized and detailed orientatedStrong MS Office skillsMust be willing and able to travel within the USA and worldwide 10% of timeAdditional Information:
This position is hybrid-onsite at the Avid office location in Philadelphia.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively âLillyâ) are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.ÂEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively âLillyâ) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Womenâs Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
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