Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? Veristat is hiring a Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA at Veristat will be client facing and will be responsible for:Leading regulatory clinical trial services ex North America, with focus on Europe.Leading regulatory activities on assigned projects, working independently and within cross functional consulting and clinical teams.Develop and lead regulatory strategy and operational implementation during product development, registration and post-approval, ensuring regulatory compliance of assigned projects.Independent preparation of regulatory documentation such as PIPs, ODDs, Scientific Advice requests and lead interactions with Health Authorities.Interactions with client contacts.Coaching junior team members.What we doFor 30 years, Veristat has built a reputation as global experts in clinical development.760+ Rare Disease Clinical Trials supported.160+ Marketing Applications supported.In 2022 we supported 8 marketing applications that received regulatory approval.What we offerA stimulating role in an international and dynamic work environment.Continuous development and training opportunities.Office or Home-Based working.Rewards for outstanding accomplishments.What we look forAn experienced Regulatory Affairs professional with 10+ years’ experience in Regulatory Affairs in the pharmaceutical industry or CRO/consultancy.Scientific Degree with preference for MSc or PhD.Experience with line management.Experience with set-up of clinical RA systems and processes, clinical trial conduct, CTIS, leading collaboration with Clinical Operations, Start up, PM, essential. Europe essential, other markets and ATMPs and GMO experience a plus.Experience with leading regulatory activities during early development, marketing authorization and post-approval phase, including agency interactions, PIPs, ODDs, Scientific Advice meetings, MAAs etc. Europe essential, other markets a plus.Global regulatory experience is a plus.Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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