Sr. Principal - 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.

ORGANISATION OVERVIEW:

At Eli Lilly Cork, 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 41,000 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 patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 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, subsidised 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 purpose of the CMC Pre-approval Sr Principal Regulatory R4 Scientist role is to partner with Global Regulatory Affairs – CMC (GRA-CMC) Regulatory Scientists to provide strategic, tactical and operational direction and support to expedite CMC development of Lilly’s portfolio by developing successful regulatory strategies and submissions in support of clinical trials and marketing authorization applications. To accomplish this purpose, it is necessary for the Scientist to develop collegial and mutually productive relationships with CMC team members. The Scientist utilizes CMC technical knowledge and regulatory expertise and lessons learned across GRA-CMC to drive internal consistency and influence effective change management.
The R4 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.

Regulatory & Scientific Expertise

• Deep technical knowledge of CMC drug development science(s)
• Demonstrates knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and product registrations.
• Assist in the development of regulatory strategy and update strategy based upon global regulatory changes.
• Provide high quality and timely regulatory advice to allow CMC teams to make well-informed decisions.
• Evaluate regulatory impact on proposed CMC development plans.
• Anticipates and resolves key technical or operational issues that can impact the function or CMC team.
• Participates in risk-benefit analysis for regulatory compliance.

Influence

• Networks and gains alignment with CMC team members and GRA CMC regulatory scientists/line management to resolve complex issues.
• Provides regulatory guidance to CMC teams and implements regulatory strategies that enable timely study starts.
• Exhibits strong Lilly leadership behaviors.
• Incorporates new regulations, guidance, and company positions into regulatory CMC processes/guidelines, tools, and/or training materials.

Lead / Partner

• Leads preparation, review and finalization of CMC documents for global CTA submissions, marketing authorization applications, and response to questions.
• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content.
• Makes technical decisions on CMC regulatory issues impacting submissions across geographies.
• Networks and gains alignment with CMC team members and GRA CMC scientists/line management to resolve complex issues.
• Develop relationships with CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.
• Communicates effectively verbally and in writing within GRA CMC and with CMC development teams.
• Proactively identifies and resolves global CMC regulatory issues, leveraging internal experts to develop complex regulatory strategies.

BASIC REQUIREMENTS:

• Bachelor’s Degree in science or engineering discipline (e.g., chemistry, biology, biochemistry or pharmacy or related scientific discipline) with 10 – 12 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing or quality
• Or master’s degree in science or engineering discipline (e.g., chemistry, biology, biochemistry or pharmacy or related scientific discipline) with 5 – 7 years experience in CMC regulatory or drug substance or drug product development, commercialization, manufacturing or quality
• Less experience would be considered with a Pharm D or a Ph.D degree in a related field.

Please refer the Job description for details