Beschreibung

In this role, you will be at the forefront of regulatory strategy for clinical trials across Europe and Canada, ensuring compliance and effective communication with health authorities. Your day-to-day responsibilities will include developing implementation plans, overseeing submissions, and collaborating with global teams to navigate the complexities of clinical trial regulations.

Anforderungen

• •BSc. advanced scientific related degree preferred or BA accepted based on experience
• •Minimum of 3 years of experience in drug regulatory affairs preferably within the EU/GEM region
• •Experience with EU CTR advantageous
• •Solid regulatory experience including knowledge of CTA regulations and guidance governing drugs and biologics
• •Basic regulatory procedure knowledge with major health authorities in the region
• •Attention to detail and ability to make reasoned recommendations
• •Ability to speak up
• •Promotion of an inclusive culture and expression of empathy for others
• •Ability to carry out assigned activities within reasonable time
• •Adaptability to changing circumstances and ability to build and maintain relationships
• •Ability to receive and give feedback; express ideas, questions, and disagreement
• •Self-awareness and ability to function effectively under challenges
• •Fluency in English

Aufgaben

• •Contribute to regulatory strategy development for clinical trials in EUCAN and GEM regions
• •Develop operational implementation plans for clinical trial applications (CTAs) in EUCAN and GEM regions
• •Execute and oversee activities related to Requests for Information (RFI) and CTA management globally
• •Ensure compliance with legal requirements and internal procedures for CTA submissions
• •Track CTA activities and eTMF updates with the International CTRL/CRO Regulatory Lead
• •Generate and maintain metrics on workload and KPIs for key CTA activities
• •Oversee interactions with health authorities during CTA assessments
• •Collaborate with global and regional counterparts on CTA regulatory activities
• •Present regional CTA regulatory strategies to senior management
• •Identify regional and national requirements for CTA submissions
• •Coordinate submission preparations and creation of administrative documents for interventional trials
• •Coordinate submission preparations for Non-Interventional Post-authorisation safety studies (PASS)
• •Develop and maintain standardized communication and planning tools for internal use
• •Ensure timely submissions and proactive communication of regulatory milestones
• •Provide regulatory oversight of CRO activities to maintain compliance
• •Support non-routine submission activities and deviation follow-up as needed
• •Provide ad-hoc guidance on submission requirements for clinical trials
• •Collaborate with the team to find solutions to problems during the CTA process
• •Maintain an internal regulatory knowledge database on emerging trends
• •Participate in the review of internal procedures and processes
• •Ensure timely and compliant submissions to the EMA Clinical Trial Information System (CTIS)
• •Coordinate submissions in the CTIS portal
• •Represent the team in workshops and cross-functional initiatives related to clinical trials
• •Engage Local Operating Company Regulatory Affairs in health authority interactions