At Opella, the Consumer Healthcare Division of Sanofi, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Job Summary:

The Global Switch Science Lead is responsible for leading the switch development program to approval of an assigned Rx-OTC Switch asset in target market (ex-US markets).  

This role involves developing and executing program strategies for global programs, interacting with cross-functional teams, and collaborating with internal and key external stakeholders. The individual will manage regulatory experts as direct report. Works closely with the Global Commercial Lead.

The ideal candidate is an experienced leader, who has a deep understanding of the Rx-OTC switch requirements and regulatory approval process, strong leadership skills, and a history of successful switch programs.

Key Responsibilities:

• Oversees, entire switch science program and associated work streams involved. This will include both direct reports and matrixed colleagues with the intent on delivering against the switch priorities.

• Oversees budget and timeline in association with project management. Provide switch science leadership to deliver against key switch milestones and within budget.
• Ensure that all documents to be submitted to regulators represent the aligned program strategy, are complete, accurate, compliant with global and/or local submission requirements and standards and are organized in a manner to facilitate regulatory review. This applies for both development and registration dossiers. Lead and actively participate in the development of strategies for Health Authority interactions.
• Proactively help to drive the business by looking at ways to deliver the switch programs in a time efficient manner whilst meeting financial spend estimates.
• Engage with and update management on progress against key deliverables.
• Represent the science team in alliance partner meetings.
• Lead external partner interactions and engagement with the cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy.
• Collaborate with stakeholders from various departments, including leadership, science, regulatory, safety, real-world evidence, and behavioral science, global medical affairs, commercial and consumer insights. Strong partnering and collaboration with the R&D and SMEs within and across switch teams.
• Understand Rx-OTC Switch, the healthcare environment (including social & policy trends); anticipate the self-care future and changes that will impact the CHC portfolio. Provide clear advice on future trends, competitive intelligence and emerging requirements for development programs and help to drive innovation.
• Serves as a switch science educational resource to both internal and external customers.
• Rx-OTC Switch Ex-US

• Understands the external and regulatory environment in ex-US markets (e.g. Europe, Japan, Australia etc.) to drive switch strategy in these markets. Establishes an overall global switch strategy utilizing insights from each target market.
• Collaborates with markets/regions, on developing the overall program strategy including their strategies regarding Regulatory Agency interactions for switch-related projects.

About You:

Education:

• Minimum B.S. An advanced degree such as MS, PhD, or PharmD or equivalent preferred.  

Experience:

• 15+ years of relevant experience with about 5 years switch experience with a track level in delivery.
• Demonstrated success in completing key switch milestones in OTC environments.
• Possesses a strong knowledge of the regulatory/medical requirements across the target markets.
• Experience in global or regional roles.
• Proven experience in Health Authority interactions and registration/approvals in ex-US countries
• Experience in clinical and consumer studies relevant to switch products is desired.

Specialized Knowledge/Skills:

• Proven history of managing direct reports, working cross-functionally collaboratively and leading projects.
• Strategic & analytical thinking; Adaptability and flexibility to constant changing business and regulatory environment.
• Excellent communicator both written and verbal.

Opella offers hybrid environment requiring 2 – 3 days in office and the requirements will vary dependent on business needs.