Director, Global Regulatory Lead

Requirements

• BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
• Experience:
• Has 8-15 years of Regulatory Affairs experience. The regulatory experience should be broad (across the life cycle of pharmaceutical products through commercialization and across main regions such as US, EU, Japan, and Canada and other) to ensure appropriate leadership and mentoring for regulatory staff within Rezolute.
• Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
• Ability to present complex issues in oral and written form.
• Experienced in responding to inquiries from HAs.

Additional Information

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity. The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies, and programs pertaining to development and marketing of Rezolute products. This role includes the support of global registration and life cycle support and includes the leadership of regulatory strategy for multiple projects that extend globally (EU, ROW, etc.) coordinating departmental and cross functional support. Position reports to the Chief Regulatory Officer Rezolute (RZLT) currently anticipates the base salary for the Director Global Regulatory Lead role could range from $240,000 to $290,000 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. 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.

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