CMC Pre-approval Regulatory Scientist

at  Lilly

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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
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 patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
The CMC Pre-approval Principal Regulatory Scientist supports the various aspects of clinical trials and marketing authorization submission management processes. The CMC Pre-approval Principal Scientist manages submission content for Drug Substance and Drug Product, and responses to questions.
The CMC Pre-approval Regulatory Scientist in partnership with the GRA-CMC Regulatory Scientist provides tactical and operational direction to expedite CMC development of Lilly’s portfolio and technical agenda by supporting clinical trial and market registration submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes.
The CMC Pre-approval Regulatory Scientist is responsible for networking with RDE CMC Regulatory Associates to ensure proper communication and adherence to workflows to deliver on time submissions and responses to questions.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelor’s degree in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 6 – 8 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing or quality
• Or master’s degree in regulatory affairs or in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences or similar) with 3 – 5 years experience in drug substance or drug product development, commercialization, manufacturing or quality
• Less experience would be considered with a Pharm D or a PhD degree in a related field.

Please refer the Job description for details