Director, Global Regulatory Lead

Rezolute•Redwood City, CA

About The Position

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.

Requirements

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 and across main regions such as US, EU, Japan, and Canada and other) to ensure appropriate leadership and mentoring for regulatory staff within Candel.
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.

Responsibilities

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 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 company’s goals.