Director, Regulatory Affairs EU
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Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities resourcing and Functional Service (FSP) solutions.
The Director Regulatory Affairs EU is responsible for leading and executing regional and global regulatory strategies to support drug and device development. This role ensures compliance with European and international regulations while enabling efficient clinical development and successful project delivery.
As part of our SRS/FSP team you will be dedicated to one sponsor a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
Key Responsibilities
Lead and Support European and global regulatory strategy support for the Business Units and support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigations
European and global support of the strategy teams at the Business Units to develop a Regulatory and Startup strategy for new device drug and combination products focused on RFPs and Projects
Developing regulatory documents and leading support for EMA and European national scientific advice / protocol assistance meetings
Lead and support regulatory development support activities including Pediatric Investigation Plans Orphan Designation and other designations/support (e.g. PRIME)
Regulatory Support of capabilities and bid defense meetings
Qualifications
Advanced degree in Life Sciences Pharmacy Medicine or a related field
Significant experience in regulatory affairs within pharmaceutical biotechnology or CRO environments
Strong knowledge of European regulatory requirements and experience with EMA and national authorities
Proven ability to lead regulatory strategy and work effectively with cross-functional and global teams
Excellent communication organizational and problem-solving skills
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration quality and making a difference in the lives of patients.
Our core values of Trust Quality Passion Flexibility and Sustainability guide our decisions and shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden in the city of Lund. As a full-service global CRO we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.
Key Skills
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more
