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Associate/Manager – CMC Regulatory

Employer
Eli Lilly and Company
Location
Philadelphia, Pennsylvania
Start date
Mar 28, 2024

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Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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 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 – 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 strategies
  • Author and review global CMC dossiers
  • Coordinate and contribute to responses to regulatory agency questions
  • Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans
  • Maintain submission information according to the Regulatory Information Management (RIM) system.
  • Support CMC regulatory assessment for change controls
  • Keep current with global regulatory guidelines applicable to CMC
  • Perform other duties as assigned.

Basic Qualifications:

  • Bachelor’s degree in chemistry, biochemistry, or related field, or advanced degree such as PharmD
  • 2 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 position

Additional Skills/Preferences:

  • Excellent technical writing skills
  • Strong communication skills with ability to work within global multi-disciplinary teams
  • Ability to plan, prioritize and handle multiple tasks concurrently
  • Ability to independently complete assigned workload with minimum supervision
  • Ability to adapt to change and work in a fast-paced environment
  • Organized and detailed orientated
  • Strong MS Office skills
  • Must be willing and able to travel within the USA and worldwide 10% of time

Additional 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 “Lilly”) 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. 

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) 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, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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