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Essential Areas of Responsibility:
- Design and implement regulatory strategies for global product registrations and lifecycle support.
- Lead regulatory sub-teams and represent regulatory on global development teams.
- Provide guidance to internal groups and assess regulatory risks for assigned projects.
Minimum Education, Experience and Skill Requirements:
- BS, MS, or advanced degree in science or healthcare with 8-15 years of regulatory experience.
- Broad experience across product lifecycle and major regions (US, EU, Japan, Canada).
- Strong ability to interpret scientific/technical information and communicate with health authorities.
Benefits:
- Comprehensive health insurance (medical, dental, vision).
- Retirement plan with 401(k) match and educational assistance.
- Vacation program, holiday pay, and fitness center reimbursement.
Rezolute
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients with severe metabolic and endocrine disorders. It is a publicly traded company driven by scientific innovation, collaboration, and integrity.