OUR CULTURAL BELIEFS
Patient Minded I act with the patient’s best interest in mind.
Client Delight I own every client experience and its impact on results.
Take Action I am empowered and empower others to act now.
Grow Talent I own my development and invest in the development of others.
Win Together I passionately connect with anyone, anywhere, anytime to achieve results.
Communication Matters I speak up to create transparent, thoughtful and timely dialogue.
Own It I hold myself and others accountable for results.
The most important aspect of the position of the Assistant/Associate Director of Regulatory Affairs is being responsible for managing the more complex regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies worldwide, with an emphasis on FDA premarket submissions. This person will assist the Regulatory Affairs Director or VP of Regulatory Affairs in the development of appropriate responses to FDA enforcement actions (e.g. Warning Letters Responses).
POSITION SUCCESS FACTORS
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED