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 do
For 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 offer
* A 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 for
* An 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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