EU Director – Regulatory Affairs

This is a fully remote position, open to applicants in United Kingdom, +4 more countries.

📋 Description

• Lead and assist in developing regulatory strategies on both European and global scales for Business Units.

• Provide support for Business Development by preparing new RFPs and formulating regulatory strategies related to device and drug development as well as clinical investigations.

• Create regulatory and startup strategies for new devices, drugs, and combination products.

• Establish and maintain regulatory and startup intelligence specific to each country.

• Generate regulatory documents and oversee support for EMA and European national scientific advice and protocol assistance meetings.

• Direct and assist in regulatory development initiatives, including Pediatric Investigation Plans, orphan designation, and other designations such as PRIME.

• Aid in the establishment of new systems for startup processes.

• Provide support for regulatory capabilities and during bid defense meetings.

• Work collaboratively with USA regulatory teams to formulate global regulatory strategies and offer regulatory guidance.

• Communicate and collaborate with other clinical development departments at TFS.

• Assist in the creation of new processes and procedures.

• Identify and cultivate strategic initiatives, including enhancements to processes.

• Engage with senior management across various disciplines.

• Ensure adherence to TFS SOPs, guidelines, as well as local laws and regulations.

⛳️ Requirements

• Bachelor's Degree, ideally in a life science field.

• Over 9 years of pertinent experience.

• Familiarity with international regulatory strategies, guidance, and support for multinational clinical trials, especially concerning EU CTR and CTIS.

• Background in supporting European scientific advice, orphan designation, and pediatric investigation plans.

• Experienced in assisting with request for proposal submissions and budget evaluations, as well as capabilities and bid defense meetings for international clients.

• Capable of thriving in a fast-paced environment with shifting priorities.

• Understanding of the fundamental terminology and science related to the assigned drugs.

• Prior experience in supporting and participating in European scientific advice meetings and similar regulatory agency interactions.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.

• The chance to make a positive impact in patients' lives.