Available Position (Company name withheld)
OPIS s.r.l.Remote
Posted October 7, 2025
Full Time
About the Company
OPIS is a global clinical CRO with over 26 years of experience, offering full-service clinical trial support from concept to closure. Specializing in Phase I-IV studies across various therapeutic areas including oncology and cardiology, OPIS leverages a highly skilled team for medical writing, statistical consultancy, and operational execution. The company's mission is to enhance global medical therapy development through disciplined operations and deep therapeutic expertise, with affiliates in 18 countries.
Job Description
OPIS is seeking a Director of Regulatory Affairs to shape regulatory strategies for international product development and approval. This is a fully remote, home-based role within a European country, reporting to the OPIS affiliate. The role involves advising clients, leading the development of regulatory strategies, managing relationships with regulatory authorities, and ensuring compliance with guidelines.
Requirements
- Act as a trusted regulatory advisor.
- Lead the development and execution of regulatory strategies.
- Manage and maintain relationships with Competent Authorities.
- Review and approve regulatory documents (IMPDs, PIPs, etc.).
- Support business development.
Benefits
- Competitive salary and benefits package
- Growth opportunities
- Innovation
- Customer success
