Director – Global Switch Regulatory

Director – Global Switch Regulatory

Requirements

• Minimum B.A./B.S.
• 8+ years of relevant regulatory experience, including switch roles.
• Strong knowledge of the regulatory requirements for Rx-to-OTC switches, registration dossier.
• Knowledge on software as medical devices, ACNU requirements or global regulatory experience is preferred.
• Recognized expert in partnering with cross functional teams at a strategic level.
• Strong ability to adapt to evolving business and regulatory environments, providing innovative solutions and strategic direction.
• Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely to both internal and external stakeholders.

Responsibilities

• Lead the regulatory strategy and execution efforts working closely with science lead and the cross-functional teams for both new products/claims as well as the future life cycle management of switch line extension opportunities including regulatory classes (drug, medical device, combination products).
• Lead the development and execution of the submission dossier and regulatory strategy for the NDA or other global regulatory submissions.
• Provide regulatory strategies, input and review for clinical and consumer studies (e.g. label comprehension study, self-selection study, actual use trial, human factors study, RWE study etc.), related to protocol, data collection instrument and study reports on different switch programs as needed.
• Drive and design the best regulatory strategy for the registration of switch candidates and respond to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
• Ensure that all documents to be submitted to regulators represent the team aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in a manner to facilitate agency review.
• Leads FDA interactions with cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, digital innovative strategies, FDA submission, labeling and claims support.
• Works within Opella and externally across US Trade Associations to identify and solve for issues and strategic aligned opportunities to promote self-care.
• Responsible for making decisions and proposing solutions on new commercial strategies for Brand names, DTC, digital tech, retail tech, ecommerce, claims in line with regulatory requirements.
• Ensure current and proposed regulatory, scientific and pertinent legal issues including analysis of potential impact are made present to the business.
• Provide leadership for regulatory strategy and intelligence for due diligence and business development initiatives.
• Serves as an educational switch resource to both internal and external customers.
• Provide clear advice on future trends, competitive intelligence and emerging FDA requirements for development programs and help to drive innovation.
• Contributes to interdepartmental projects
• Proactively help to drive the business proposing solutions to both internal and external challenges, shaping the external switch regulatory environment.

Preferred Qualifications

• An advanced degree such as MS or equivalent preferred.
• Knowledge on software as medical devices, ACNU requirements or global regulatory experience is preferred.