Principal Scientist - Global Regulatory Affairs (Cmc)

3-7 years

Not Disclosed

Cork

10 Jan. 29, 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: Principal Scientist - Global Regulatory Affairs (CMC)
Location: Kinsale, Cork, Ireland
Job Type: Full-Time, Regular
Job Id: R-78632

About Lilly:
At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, we are committed to discovering, developing, and delivering life-changing medicines. Our employees across the globe work to address unmet medical needs, improve disease management, and support communities through philanthropy and volunteerism. We value integrity, excellence, and respect for people, and we are seeking motivated individuals to help us advance our mission.

Organization Overview:
Lilly’s Regulatory Affairs Department plays a crucial role in managing global submissions and post-approval change management for both new and existing products. The department ensures regulatory compliance and the reliable supply of medicines across the globe, supporting the development and approval of New Chemical Entities (NCEs) and New Molecular Entities (NMEs).

Position Overview:
We are seeking a Principal Scientist - Global Regulatory Affairs (CMC) to provide strategic, tactical, and operational direction for the CMC (Chemistry, Manufacturing, and Controls) development of Lilly’s portfolio. This role will support global clinical trial submissions, market registration, and post-approval submissions, ensuring compliance with global regulations and industry guidelines. The successful candidate will have a deep technical knowledge of CMC development and manufacturing processes, alongside the ability to influence and collaborate across teams.

Key Responsibilities:

Oversee preparation, documentation, and submission of regulatory filings for assigned products.
Lead and develop regulatory strategies in collaboration with other departments, including TS/MS (process/technology transfer), manufacturing, and quality control/assurance teams.
Manage regulatory submission timelines and monitor approval status, providing timely communication of any changes.
Ensure compliance of GMP (Good Manufacturing Practice) documents with regulatory commitments, and support batch release processes (e.g., review/approval of deviations, status of changes).
Provide regulatory guidance on changes, deviations, reprocessing proposals, validation protocols, and stability studies.
Participate in Lilly’s Global Regulatory Affairs-CMC team to share best practices, contribute to internal guidelines, and drive initiatives.
Represent Lilly at industry association meetings (e.g., PCI), and influence revisions to regulatory guidance documents.
Provide training on product registration requirements and applicable regulations to site personnel.
Stay up to date with current regulatory and technical trends, sharing insights with the team to drive continuous improvement.

Minimum Qualifications:

Education: Level 8 Bachelor's degree in a scientific discipline (e.g., chemistry, biology, biochemistry, pharmacy, or related field).
Experience:
- 3-7 years of prior Regulatory CMC experience or equivalent combination of technical and regulatory knowledge, including experience preparing regulatory submission content in a technical function.
- Pharmaceutical industry experience in CMC-related fields (5-7 years) is preferred.

Additional Skills & Preferences:

Strong knowledge of pharmaceutical/biopharmaceutical regulatory and compliance guidelines.
Excellent attention to detail and effective teamwork skills.
Proven ability to influence decision-making within and outside the organization.
Leadership skills with the ability to influence and develop in an international matrix environment.
Strong verbal and written communication skills.
Proficiency in Microsoft Office applications for creating and presenting work.
Highly organized with the ability to prioritize tasks and work independently, both as part of a team and on individual projects.

Additional Information:

This is a hybrid role based in Kinsale, Cork, Ireland.
The role involves leading and contributing to corporate improvement efforts both locally and internationally.
The successful candidate will be expected to attend training, conferences, or association meetings to remain current on regulatory and technical trends.

Commitment to Diversity and Inclusion:
Lilly is an equal opportunity employer. We are committed to creating an inclusive environment where people from diverse backgrounds, experiences, and identities can thrive. We are dedicated to helping individuals with disabilities engage in the workforce and offer accommodation support through the application process.

#WeAreLilly

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Principal Scientist - Global Regulatory Affairs (Cmc)

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