Remote Director, Regulatory Compliance

Summary

Join Hims & Hers Health, Inc. as a Director of Regulatory Compliance to lead the Quality Assurance team in identifying and managing compliance risks across various product types.

Requirements

• Pharm D (preferred) or Bachelor’s degree with equivalent experience
• Minimum 7-10 years of experience in a regulatory compliance role for USP and cGMP
• Effective knowledge of federal and state laws, rules and regulations related to the 503A and 503B compounding
• Excellent attention to detail and ability to identify potential compliance issues
• Ability to effectively lead & communicate cross-functionally in a remote environment

Responsibilities

• Create, enact, and continually improve the overall Regulatory Compliance strategy for pharmacy, compounding & OTC products types
• Act as resource for regulatory compliance for R&D and internal cross functional teams to provide clear, concise and accurate information related to product compliance requirements
• Interpret and ensure compliance with federal and state regulations as they relate to compounding practices for both 503A pharmacies and 503B outsourcing facilities
• Assist in the development and implementation strategy for compliance with current Good Manufacturing Practices (cGMP)
• Works with medical affairs and Cx teams in tracking and reporting the necessary complaints or ADEs
• Track product safety & compliance regulatory changes and communicate potential impact to the business in a timely and proactive manner
• Investigate, resolve, track and trend any potential compliance issues or violations
• Communicate with external regulatory bodies as needed to ensure compliance
• Develop and implement compliance auditing and monitoring strategies
• Assist in the identification, implementation, and maintenance of compliance policies, procedures and work instructions
• Help to develop and review Standard Operating Procedures (SOPs) to ensure regulatory compliance
• Stay abreast of state board of pharmacy regulations and guidelines relevant to compounding
• Stay involved, informed and abreast of the evolving advocacy landscape and proactively engaging in ongoing efforts
• Interact with regulatory agencies to facilitate clear communication and resolve regulatory issues
• Collaborate with cross-functional teams to implement and maintain quality systems and processes for compliance to regulatory requirements
• Maintain regulatory documentation library
• Support any change control and Corrective/Preventive Action items, agency or state board inspection observations to verify implementation and effectiveness
• Communicate compliance trends to leadership

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution