Denali Therapeutics Inc
Senior Director, International Regulatory Affairs(m/w/x)
Vollzeit
Keine Angabe
Zürich
TA
Takeda Pharmaceuticals International AG3 Monate
Manager, International Clinical Trial Regulatory Lead(m/w/x)
Management
Vollzeit
Keine Angabe
Zürich
Nejo KI-Zusammenfassung
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.
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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
Bachelor-Abschluss
Berufserfahrung
3 Jahre
Deine 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
Sprachen
Englisch – verhandlungssicher
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