Rezolute

Director, Global Regulatory Lead

Redwood City · Director

Sponsorship not specified$240k-$290kDetected 75 days ago

FDA RegulatoryLeadershipCollaborationMentoringRegulatory Affairs

About the role

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

Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
Single point of contact and accountability for regulatory and leads the regulatory sub teams as well as represents regulatory on global development teams.
Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., CTAs, MAAs and other relevant regulatory filings.
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders.
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.
Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.

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 fo

Health Insurance (Medical / Dental / Vision)
Disability, Life & Long-Term Care Insurance
Tracking Free Vacation Program
Educational Assistance Benefit
Fitness Center Reimbursement
Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.

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.
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.

This listing is sourced directly from Rezolute's careers page and normalized into a canonical job model.