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Cmc Pre-Approval Regulatory Scientist

3-5 years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: CMC Pre-approval Regulatory Scientist (12-month Fixed Term)

Location: Cork, Cork, Ireland

Category: Research & Development

Job Type: Full Time, Fixed Term

About Eli Lilly:

At Lilly, we unite caring with discovery to make life better for people around the world. With over 140 years of experience in discovering medicines that change lives, Eli Lilly remains at the forefront of innovative research. Our team, made up of more than 45,000 employees globally, works together to solve the world’s greatest health challenges. We’re looking for passionate, determined individuals to make a difference in patients' lives.

Eli Lilly Cork is home to a diverse, talented team of over 2,000 employees from more than 60 nationalities. Our campus in Little Island offers flexible hybrid working, healthcare, pension, and life assurance benefits, along with on-site amenities like a gym, subsidized canteen, and parking. We are committed to diversity, equity, and inclusion, ensuring an inclusive environment for all.

Role Overview:

The CMC Pre-approval Regulatory Scientist is responsible for managing the regulatory aspects of clinical trial and marketing authorization submission processes. You will work closely with internal teams and provide operational direction for CMC (Chemistry, Manufacturing, and Controls) development, helping to expedite the regulatory approval of Lilly’s portfolio.

This role will focus on the preparation of regulatory submission content related to drug substance and drug product, and responses to regulatory questions. You will partner with various departments to deliver on-time submissions and ensure adherence to regulatory requirements.

This is a 12-month fixed term position based in Cork, Ireland.

Primary Responsibilities:

Regulatory & Scientific Expertise

  • Plan and prepare submission content and responses for clinical trials and marketing authorization applications.
  • Manage internal requirements and documentation within GRA (Global Regulatory Affairs) and with internal Lilly partners (Development, TS/MS, Quality, etc.).
  • Develop and execute regulatory strategies in collaboration with GRA-CMC Regulatory Scientists, development, TS/MS, and quality teams.
  • Manage submission timelines and monitor approval status, ensuring timely communication of any status changes.
  • Collaborate with RDE CMC Regulatory Associates to support clinical trial and product submissions.

Leadership and Collaboration

  • Foster an open and collaborative environment within the Global Regulatory Area and CMC teams to encourage constructive discussions and robust decision-making.
  • Leverage internal forums to share regulatory expertise and ensure critical trial submissions and product registrations are met on time.
  • Guide and influence workgroups on life-cycle management processes, ensuring efficient and effective regulatory practices.
  • Demonstrate strong problem-solving skills and effectively communicate regulatory challenges across functions and geographies.

Minimum Qualifications:

  • Bachelor’s degree in a science, engineering, or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Analytical Sciences, or similar) with 6-8 years of experience in CMC regulatory or drug substance/product development, commercialization, manufacturing, or quality; or a Master’s degree in regulatory affairs or a science-related field with 3-5 years of experience in drug substance/product development or related areas.
  • Less experience may be considered with a PharmD or PhD in a related field.

Additional Preferences:

  • Experience in pharmaceutical industry CMC technical drug development.
  • Prior experience in authoring CMC submission content is desirable.
  • Knowledge of regulatory CMC requirements and technical guidance.
  • Strong written and spoken communication skills, with the ability to effectively present and negotiate.
  • Excellent attention to detail, organizational skills, and ability to prioritize tasks.
  • Proven ability to work effectively in diverse, cross-functional teams.

Additional Information:

  • Travel: Limited, up to 10%, including international travel for conferences or training.
  • Employment Type: Full-time, 12-month fixed term contract.

Eli Lilly is committed to an inclusive and accessible work environment, providing accommodations as needed to support individuals during the hiring process. If you require an accommodation, please complete the accommodation request form on our careers page.

Lilly is an Equal Opportunity Employer, and we do not discriminate based on race, ethnicity, gender, sexual orientation, disability, or other legally protected status.

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