Job Description: Regulatory Scientist at Lilly Cork
We are seeking a dedicated Regulatory Scientist to join Lilly's Cork team, focusing on global marketing authorization submissions for pharmaceutical products. This role involves managing submission content, providing guidance on regulatory structure, and supporting post-approval processes, with a strong emphasis on compliance with global regulations and manufacturing processes.
Primary Responsibilities:
1. Provide regulatory support for Drug Substances and Drug Products, including preparing documentation for marketing authorizations.
2. Manage outsourcing activities and contract manufacturers in partnership with GRA-CMC Regulatory Scientists.
3. Ensure successful preparation of CMC dossiers and variation packages.
4. Develop and execute regulatory strategies in collaboration with cross-functional teams.
5. Prepare CMC CTD content, manage submission timelines, and support post-approval changes.
6. Support product lifecycle management activities such as site registrations and license renewals.
7. Review and approve regulatory documents, including CMC dossiers and variation packages.
8. Foster an environment of open discussion and continuous regulatory expertise development.
Qualifications:
* Minimum a college degree (BSc), with an advanced degree (MSc, PhD, PharmD) preferred in biological or life sciences.
* Solid regulatory experience in pharmaceutical or biotech settings.
* Strong knowledge of regulatory guidelines, GMP compliance, and manufacturing processes.
* Excellent communication, organizational, and teamwork skills.
* Proficiency in RIM and Microsoft Office applications.
Lilly is committed to diversity and equal opportunity employment, welcoming applicants regardless of age, race, gender, or protected status.
#J-18808-Ljbffr