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Job Description
Regulatory Scientist - CMC
Lead the development and submission of regulatory documents for pharmaceutical products, ensuring compliance with global regulations and guidelines.
- Provide regulatory support for existing Drug Substances and Drug Products
- Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities & contract manufacturers
- Ensure successful preparation of CMC dossiers and variation packages to support product submissions
- Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities
- Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements
- Manage submission timelines with relevant teams and monitor approval status
- Partner with RDE CMC Regulatory Associates to effectively support product lifecycle maintenance
Key Responsibilities:
- Regulatory Expertise
- Lead, Influence, Partner
Requirements:
- Minimum a college degree (BSc), ideally an advanced degree (MSc, Ph D, Pharm D preferred)
- Strong knowledge of regulatory and compliance guidelines within pharmaceuticals / biopharmaceuticals
- Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance
- Proven ability to effectively influence within and beyond the GRA organization
- Excellent verbal and written communication skills
- Good organizational skills, with the ability to prioritize and be self-motivating
- Proven effective teamwork skills
About Lilly:
- Lilly is a global healthcare leader headquartered in Indianapolis, Indiana
- We unite caring with discovery to make life better for people around the world
- We are a global healthcare leader with a diverse team of over 1,400 employees across 38 nationalities