Director of Regulatory and Medical Affairs

Job Summary The Director of Regulatory and Medical Affairs will provide strategic leadership and oversight for regulatory and medical affairs activities at Sprout Pharmaceuticals, a leading pharmaceutical company dedicated to breakthroughs in women's health. This role is responsible for ensuring regulatory compliance, developing and executing strategies for medical outreach, and ensuring timely and quality regulatory submissions and follow-ups. The ideal candidate will possess experience in the pharmaceutical space with a proven ability to ensure compliance with regulatory, medical, and industry standards and leverage up-to-date regulatory insights to help guide business strategy.Essential Functions Lead the development and execution of regulatory strategies, ensuring alignment with business objectives and adherence to national and global regulatory standardsManage company regulatory reporting including annual reporting and filings for new indications as needed Continually monitor and stay informed on evolving regulatory guidelines and industry trends. Identify and assess the impact of regulatory changes on the company's business strategyIdentify and assess regulatory and medical risks, developing mitigation strategies to address potential issuesOversee medical affairs functions and manage day-to-day medical information activities and pharmacovigilance reporting Develop and execute comprehensive medical outreach strategies to enhance awareness and understanding of the company's product and researchOversee the development of medical communication materials, including publications, presentations, and educational contentEnsure that all medical materials and outreach activities comply with relevant regulations, industry standards, and company policiesBuild and maintain product and therapeutic area expertise with consistent monitoring of current literatureManage outside consultants and vendors as needed RequirementsAdvanced degree (MD, PharmD, PhD, NPR, PA) in a relevant scientific or medical fieldMinimum of 8 years of experience in regulatory affairs and medical affairs, with at least 5 years in a senior leadership role, preferably with experience in the field of women's healthProven track record of developing and implementing successful medical outreach programs and material development strategiesIn-depth knowledge of US regulatory requirements and medical affairs best practicesExcellent communication and collaboration skills, with the ability to work cross-functionallyCreative problem-solving skills and attention to detailEntrepreneurial spirit and the ability to think strategically and creatively to achieve sales goals and lead, influence, meet, and adapt to changing needs of the healthcare industry, our Sprout team, and the external customers we supportStrong business acumen and problem-solving ability, ability to analyze quantitative data and extract essential elements to build business plans and provide clear direction and feedback on how to achieve the desired resultsDemonstrated ability to manage changing priorities and ambiguity while maintaining direction and focus through proactive planning and organized approaches to workDemonstrated ability to thrive in a highly complex environment, ability to work cross- functionally and share successes and best practicesProficient with Microsoft Office (Word, Excel, PowerPoint), e-mail, digital communication platforms and AI tools and technologiesWhat We OfferA diverse and inclusive workplace that celebrates innovationCompetitive salary and benefits package, including health, dental, life and vision insurance with a 401k and generous paid time off and paid holidaysOpportunities for professional development within a growing leader in women's health

Created: 2025-03-08