Director, Global Regulatory Lead
Job Location:
Redwood City, CA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
- 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.
- Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for assigned projects.
- 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.
- Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
- Oversee ex-US regulatory representatives and consultants
- Provides guidance to all appropriate departments to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance interprets and notifies appropriate personnel and works with regulatory policy/intel.
- Makes recommendations for regulatory department operating procedures.
- May be involved in participating as the Regulatory reviewer in formal MLR and Promotional Review Board activities
- May be responsible for creating and reviewing SOPs.
- May supervise Regulatory Affairs Associates.
- Consistently works with abstract ideas or situations across functional areas of the business.
- Through assessment of intangible variables identifies and evaluates fundamental issues providing strategy and directions for major functional areas.
- Requires in-depth knowledge of the functional area business strategies and the companys goals.
Education:
- BS BSc MS MSc PhD PharmD J.D. or M.D. in science or healthcare preferred or equivalent relevant 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.
Rezolute (RZLT) currently anticipates the base salary for the Director Global Regulatory Lead role could range from $240000 to $290000 and will depend in part on the successful candidates 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 Companys 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.
Required Experience:
Director
About Company
Rezolute is a clinical‑stage biopharmaceutical company developing transformative therapies—such as the monoclonal antibody ersodetug (RZ358) in Phase 3 for congenital hyperinsulinism and the oral plasma kallikrein inhibitor RZ402 in Phase 2 for diabetic macular edema—to treat rare met ... View more
