hims & hers is hiring a
Director, Regulatory Compliance
hims & hers
π΅ $170k-$210k
πRemote - Worldwide
Please let hims & hers know you found this job on JobsCollider. Thanks! π
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 Bachelorβs 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
Share this job:
Disclaimer: Please check that the job is real before you apply. Applying might take you to another website that we don't own. Please be aware that any actions taken during the application process are solely your responsibility, and we bear no responsibility for any outcomes.
Similar Jobs
- π°$160k-$180kπUnited States
- π°$165k-$200kπUnited States
- π°$101k-$182kπUnited States
- π°~$130k-$200kπWorldwide
- π°$175k-$220kπUnited States
- π°~$190k-$240kπWorldwide
- π°~$220k-$297kπUnited States
- π°~$182kπUnited States
- π°~$190k-$240kπUnited States
Please let hims & hers know you found this job on JobsCollider. Thanks! π