Start Date
Immediate
Expiry Date
05 Aug, 25
Salary
90000.0
Posted On
06 May, 25
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Life Sciences, Communication Skills, Long Term Care Insurance, Ethnicity, Regulatory Requirements, Regulatory Affairs, Biotechnology Industry, Ema, Health Insurance, Regulatory Submissions
Industry
Pharmaceuticals
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tumorHI).
The Associate /Senior Associate, Regulatory Affairs – Regulatory Operations reports to the Senior Director of Regulatory Affairs and is responsible for the day-to-day support of eCTD submissions to the FDA and other Health Authorities in all therapeutic areas worldwide. They will play a key role in supporting regulatory submissions and compliance activities to ensure timely and high-quality submissions to global health authorities. This position will work cross-functionally with Regulatory Affairs, Clinical, CMC, and external partners to facilitate the preparation, submission, and maintenance of regulatory applications
QUALIFICATIONS & EXPERIENCE:
Qualifying employees are eligible to participate in benefit programs such as:
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class