Director - Regulatory Compliance
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.
