US Regulatory Lead

4 weeks ago


Trenton, United States Haleon Full time

US Regulatory Lead – Rx to OTC Switch Location: Warren, NJ (Hybrid) Hello. We’re Haleon. A new world-leading consumer health company. Together, we’re improving everyday health for billions of people through a global portfolio of category-leading brands. About the role The US Regulatory Lead of Rx to OTC Switch is a key strategic member of the North American Regulatory Affairs Leadership Team (NA RALT), providing dedicated support to the Rx to OTC Switch team and directly accountable for driving all regulatory aspects of the US Switch portfolio. This role reports into the VP and Head of US Regulatory Affairs and has strong dotted line reporting into the VP Rx to OTC Switch. The individual will develop and execute regulatory strategies that meet regulatory requirements, business objectives, and consumer needs. A key expectation of the role is to guide the team in successfully navigating a complex FDA regulatory landscape, building strong relationships with all stakeholders to influence positive outcomes. Role Responsibilities Active Haleon Representative on Industry trade associations to advance the Self-Care initiatives related to Rx to OTC Switch. Lead Regulatory assessments of new opportunities, assessing feasibility based on a comprehensive evaluation of the science and the issues likely to be raised by the Switch. Set the Switch Regulatory Strategy and Execution plan, establishing key milestones to progress Switch programs. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the evolving regulatory environment. Lead Switch regulatory intelligence evaluation and communication process to guide strategic portfolio choices. Deliver clear, compelling, and well-constructed regulatory communications for internal and external audiences. Determine the best mechanism for FDA interactions to achieve switch objectives and lead interactions with regulatory authorities. Collaborate with Government Affairs and cross-functional partners to advocate for regulatory reforms. Why you? Basic Qualifications: Bachelor’s degree in Life Sciences. 10 years of Regulatory Affairs leadership experience with a track record of external influence. Knowledge and experience with INDs, NDAs, and drug development requirements. Experience in OTC, consumer healthcare, nutritional and/or FMCG. Demonstrated ability to influence and collaborate cross-functionally. Strong communication skills and able to influence internally and externally. Strategic thinking including setting and implementing a clear vision and direction. Preferred Qualifications: Advanced Degree in Life Sciences. Strong partnership with commercial teams. Experience as an internal and external influencer/spokesperson for R&D. Commercial financials and budget management experience. Resilient and makes courageous decisions while navigating complexity. This job posting closes on: August 22, 2024. The salary range for this role is: $196,416 to $270,072 plus a 18% annual target bonus. Haleon is an Equal Opportunity Employer. We embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. #J-18808-Ljbffr



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