Expiry Date: 08-03-2021
Category Clinical Research
Job Type: Full Time
Regulatory Affairs US Liaison, then move into a Global Regulatory Leader role - Based in RTP
We have a new role open for a strong and confident Regulatory Affairs professional to operate as the US Regulatory lead for both early and/or late stage development assets, across neurology and immunology disease areas.
Location: Atlanta, Georgia
Initially you will start as the Regulatory Affairs Liaison working with clinical development for both small molecules and biologics, responsible for strategic implementation of drug development programs with submissions in the US, Canada, and Latin America. The next step will be to move into a global role overseeing assets via your regional liaisons for both the US and EU regions as well as all major international/global territories, in a more “hands-off” strategic position, guiding (and sometimes teaching) your liaisons though each stage of development providing the appropriate expertise for regulatory input into clinical development as well as successful health authority interactions and new filings.
My client offers a great working environment where people are proud of what they do, and how they do it. From humble beginnings to now ensuring their long-term success, the people here have been proud and happy to witness the growth of this organisation from a mature products company to a thriving Biotech with over 20 indications in development. With a culture of continuous learning you will be inspired and motivated by those around you, who always feel supported in their quest for finding strong and successful patient centric solutions.
The regulatory team in particular are a great team, who are dedicated and passionate about learning more in an ever evolving industry. The department has a strong voice and are focused on implementing agile methodologies and ways of working, and you will be encouraged to continually build your skills throughout your time here. Their flexible working really promotes and allows people to work in a way that suits their home lives while also spending time on activities that will help their personal development and growth. The leadership style here is focused on encouraging individuals to take the initiative, promoting cross-functional cooperation, and thinking in networks, in order to make all things possible!
Ideal candidates….My client is not looking for an ideal candidate, instead they are interested in talking to people who have a strong vision and philosophy around developing agile regulatory strategies that support clinical development and know how to influence teams to be able to anticipate and pivot plans based on emerging data. They would like to speak to results-driven regulatory leaders with both the passion and track record to successfully steer people and projects through complex regulatory pathways to achieve new treatment options! They would like to speak to people who enjoy working in the development space, who want the space, partnerships and positive environment in which they can showcase their experience in a friendly and forward thinking culture.
To apply, please contact me, Theo Moore on US toll-free 855 505 1382, or send a full CV to Theo@AdvTalent.com - please feel free to call us during working hours or on Saturday or Sunday AM (Eastern time)! Alternatively, please press the red “Apply for position” button and follow the registration process.
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