What are the responsibilities and job description for the Regulatory Specialist position at Actalent?
Description:
Process all initial regulatory documents for submission to the Pharmaceutical Sponsors and Institutional Review Board (IRB) Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees Prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA.
Skills:
irb, regulatory, submission, adverse events
Top Skills Details:
irb, regulatory, submission, adverse events
Additional Skills & Qualifications:
MUST HAVE Experience submitting to the IRB a minimum of 10 times A Bachelor’s Degree and 3 years to 5 years of experience or equivalent combination of education and experience is required. 1-3 years relevant experience in an academic regulatory environment IND/IDE/Clinical Trial Application experience Knowledge and experience with FDA Clinical Trial regulations and guidance’s Demonstrated ability to work on projects with some independence Strong writing skills Review and edit policies Ability to work in a team environment and independently
Experience Level:
Intermediate Level
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
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $28 - $31