Description:Developing and implementing global and/or US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.Skills:Regulatory affairs, regulatory strategy, Fda, Regulatory submissionAdditional Skills & Qualifications:Must haves:
US drug development and regulatory policy experience .
Experience leading major submissions and FDA meetings
Experience working on multiple projects simultaneously
Understanding of GMPs, GLPS and GCPs
Bachelor's degree
5-7 years of experience
Experience Level:Expert LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.