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 standards
Manage 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 strategy
Identify and assess regulatory and medical risks, developing mitigation strategies to address potential issues
Oversee 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 research
Oversee the development of medical communication materials, including publications, presentations, and educational content
Ensure that all medical materials and outreach activities comply with relevant regulations, industry standards, and company policies
Build and maintain product and therapeutic area expertise with consistent monitoring of current literature
Manage outside consultants and vendors as needed
Requirements
Advanced degree (MD, PharmD, PhD, NPR, PA) in a relevant scientific or medical field
Minimum 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 health
Proven track record of developing and implementing successful medical outreach programs and material development strategies
In-depth knowledge of US regulatory requirements and medical affairs best practices
Excellent communication and collaboration skills, with the ability to work cross-functionally
Creative problem-solving skills and attention to detail
Entrepreneurial 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 support
Strong 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 results
Demonstrated ability to manage changing priorities and ambiguity while maintaining direction and focus through proactive planning and organized approaches to work
Demonstrated ability to thrive in a highly complex environment, ability to work cross- functionally and share successes and best practices
Proficient with Microsoft Office (Word, Excel, PowerPoint), e-mail, digital communication platforms and AI tools and technologies
What We Offer
A diverse and inclusive workplace that celebrates innovation
Competitive salary and benefits package, including health, dental, life and vision insurance with a 401k and generous paid time off and paid holidays
Opportunities for professional development within a growing leader in women's health