- Lead, develop and implement the global RA strategy for assigned project.
- Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams
- Present and defend regulatory plans to internal governance bodies
- Represent as the primary interface for FDA/EMA/other Regulatory Agencies on assigned projects, including coordinating and leading meetings with these Agencies.
- Be accountable for the preparation of submissions in several jurisdictions, such as: INDs/CTAs, Briefing Documents to support meetings with Regulatory Agencies, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc
- Work closely with functional experts to coordinate their contributions to regulatory documents
- Review and approve documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, etc
- Manage and oversee external vendors, such as CROs
- Contribute to the assessment of new in-licensing opportunities and represents RA in out-licensing teams
- Maintains knowledge of global competitive and regulatory landscape
- Contribute to the assessment of the impact that changes might have on assigned projects
- Contribute to establishing and revising standard operational procedures to maximize the efficiency of processes and ensure compliance to regulations.
- Leads regulatory sub-teams, as appropriate.
- Coaches junior RA professionals and may have line function management responsibilities.
- Bachelor’s degree in life-sciences; a higher degree is preferred
- At least 10 years of regulatory affairs experience in the field of innovative new drugs, preferably in oncology or anti-infectives, with thorough knowledge of the overall drug development process. Experience with regulatory strategies for life-cycle management is an additional asset.
- Demonstrated experience with:
- Development and implementation of regulatory strategies for innovative new drugs, from pre-clinical stages up to registration.
- Experience with NDA/MAA submissions or post-marketing activities is an additional asset
- Leading cross-functional teams for preparation of regulatory deliverables
- Various regulatory procedures in the U.S. and Europe; experience with regulatory procedures in other jurisdictions is an additional asset
- Managing and overseeing regulatory activities for global clinical trials up to phase III.
- Leading meetings with Regulatory Agencies
- You are independent, results driven, team-oriented with the ability to work in cross-functional teams within a matrix organization
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Demonstrate excellent written and verbal communication skills in English
|Job Category||LIFE SCIENCES, REGULATORY AFFAIRS|