CMC Pre-Approval Regulatory Scientist

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.

12 month fixed term position

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

• Plan and prepare submission content and responses to questions for clinical trials and marketing authorization applications.
• Manage internal requirements and documentation within GRA and with internal Lilly partners (Development, TS/MS, Quality, etc).
• Develop, plan and execute appropriate regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives, such as development, TS/MS, and quality.
• Manage submission timelines with relevant teams (e.g., development, TS/MS, clinical teams), monitor approval status and communicate change status to interested personnel in a timely manner.
• Partner with RDE CMC Regulatory Associates to effectively support clinical trial and product submissions.

Lead, Influence, Partner

• Create an environment within the Global Regulatory Area and across CMC teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
• Leverage internal forums to continue to develop and share regulatory expertise to meet critical clinical trial submissions/product registration timelines and electronic submission structure and content requirements.
• Communicate effectively to guide and influence within work group/function regarding life-cycle management processes.
• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies.

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.

Other Information/Additional Preferences:

• Pharmaceutical industry experience in CMC technical drug development desirable
• Prior experience authoring CMC submission content is desirable.
• Prior Regulatory CMC experience or equivalent combination of technical and regulatory guidance knowledge is desirable.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated negotiation and influence skills.
• Demonstrated attention to detail and ability to prioritize effectively.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes 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.

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