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:

• Bachelor’s or Master’s degree in life sciences, pharmacy, or a related field.
• 2-5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, preferably in a clinical-stage company.
• Strong knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Experience preparing and managing regulatory submissions for investigational and marketing applications.
• Excellent organizational skills with the ability to manage multiple projects and deadlines.
• Strong written and verbal communication skills.
• Proficiency in regulatory information management systems and electronic submission software .
  Rezolute (RZLT) currently anticipates the base salary for the Associate /Senior Associate, Regulatory Affairs – Regulatory Operations role could range from $90,000 to $110,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Rezolute offers competitive compensation, stock options and a rich benefits package.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability, Life & Long-Term Care Insurance
• Holiday Pay
• Tracking Free Vacation Program
• 401(k) Plan Match
• Educational Assistance Benefit
• Fitness Center Reimbursement

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

• Be responsible for archiving all regulatory communications between Sponsor, global Health Authorities, affiliates, and contractors
• Lead the development of Regulatory infrastructure (databases, systems, and tools) used to support day-to-day Department activities
• Provided leadership in the support and management of eCTD submissions software (e.g., author formatting tools, ISI toolbox upgrades, electronic document management systems, etc.), including the development or modification of its processes.
• Support daily submission activities, including the assembly of regulatory Submissions to US FDA in eCTD format
• Assist in the preparation, compilation, and submission of regulatory documents, including INDs, CTAs, NDAs, BLAs, MAAs, and associated amendments and supplements, including managing an external publisher
• Coordinate with cross-functional teams (clinical, nonclinical, CMC, etc.) to gather necessary documentation for regulatory submissions.
• Support internal audits and inspections by regulatory agencies. Maintain and track regulatory commitments, correspondence, and filings to ensure compliance with health authority requirements.
• Monitor regulatory intelligence and changes in global regulatory requirements to assess potential impact on company programs.
• Ensure compliance with electronic submission requirements and manage regulatory information systems.
• Contribute to process improvement initiatives within the Regulatory Operations function.