Hims & Hers Health, Inc. (better known as Hims & Hers) is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space. Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.
Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS”. To learn more about the brand and offerings, you can visit hims.com and forhers.com, or visit our investor site. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.
About the Role:
The Director of Regulatory Compliance will be a key member of the Quality Assurance team and will be responsible for identifying and effectively managing compliance risks across a range of existing and new product types, and creating, and continually improving the overall Product Compliance strategy. You will report to the SVP of Pharmacy Safety, Quality and Compliance, and work closely with internal cross functional teams to monitor and interpret changes in regulations, track product compliance regulatory changes, support the development of our innovative format delivery systems and ensure operations are in line with current industry standards and best practices.
You Will:
- 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, and to ensure compliance with relevant laws and regulations
- 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.
- Comfortable working in a fluid environment, managing fluctuating priorities.
You Have:
- Pharm D (preferred) or Bachelor’s degree with equivalent experience (Required)
- 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
- Experience with Board of Pharmacy, FDA, DEA audits a plus
- Experience with accreditation boards a plus
- Excellent leadership and communication skills, with the ability to effectively collaborate with cross-functional teams and senior executives.
- Up to 35% travel
Our Benefits (there are more but here are some highlights):
- 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
- Offsite team retreats
Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.
Outlined below is a reasonable estimate of H&H’s compensation range for this role for US-based candidates. If you're based outside of the US, your recruiter will be able to provide you with an estimated salary range for your location.
The actual amount will take into account a range of factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and location. H&H also offers a comprehensive Total Rewards package that may include an equity grant.
Consult with your Recruiter during any potential screening to determine a more targeted range based on location and job-related factors.
An estimate of the current salary range for US-based employees is
$170,000—$210,000 USD
We are focused on building a diverse and inclusive workforce. If you’re excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
Hims is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. Hims considers all qualified applicants in accordance with the San Francisco Fair Chance Ordinance.
Hims & hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at accommodations@forhims.com. Please do not send resumes to this email address.
For our California-based applicants – Please see our California Employment Candidate Privacy Policy to learn more about how we collect, use, retain, and disclose Personal Information.
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Last updated on Aug 19, 2024