What are the responsibilities and job description for the Regulatory and Legal Affairs Specialist position at Avita Pharmacy?
Overview:
Avita Care Solutions offers a comprehensive benefits package:
The Regulatory and Legal Affairs Specialist is responsible for providing expert guidance and support to ensure regulatory compliance with state and federal requirements, drug purchasing accounts, internal audits, 340B patient eligibility compliance, and monitoring and reporting company compliance performance. Additionally provides support to the General Counsel on regulatory and contract compliance within the company.
This is a full-time, hybrid position based in Plano, TX.
Flexible work schedule. Great work-life balance!
About the Role:
- Assist with the submission, request, negotiations, and reaccreditation of third-party pharmacy benefit contracts
- Confirm and validate contract integrity
- Assist with the submission and processing of regulatory licensing documents such as State Board of Pharmacy licenses, National Council for Prescription Drug Programs registration, National Provider Identification Numbers, DEA Registrations, Secretary of State registrations, Seller’s Permits, and Business Licenses
- Assist with drafting, reviewing, and coordinating pharmacy services agreements and other contracts
- Ensure compliance with 340B regulatory requirements via ongoing 340B monitoring, education, and internal audits
- Maintain and report monthly compliance report cards detailing compliance levels and organization’s risk exposure
- Maintain up-to-date knowledge of current and upcoming changes in the regulatory environment affecting the organization’s business model
- Working with various departments and stakeholders to ensure regulatory compliance.
- Providing legal research and analysis on regulatory matters
- Assisting with the preparation of legal documents and contracts
- Supporting legal teams with regulatory investigations and litigation
- Preparing and submitting regulatory filings and reports
- Responding to regulatory inquiries and audit
- Perform other related duties as assigned
- Perform in accordance with company policies and standards
- Embrace and perform in the spirit of the company’s core values and goals
About You:
- Bachelor’s degree required;Master’s degree preferred; healthcare or legal related field of study preferred
- 5 years of legal/compliance experience preferred
- Strong Microsoft 365 skills, especially in areas such as drafting and editing
- Self-motivated and detail-oriented with strong organizational skills
- Proven ability to exercise good business judgment, maintain confidentiality, and act in a diplomatic manner
- Ability to communicate effectively and succinctly to appropriate stakeholders
- Ability to prioritize and manage various projects to meet deadlines in a fast-paced work environment
- Ability to work collaboratively and professionally within a team setting
At Avita Care Solutions, compassionate care is at the heart of everything we do. Join Avita and get inspired to be the care that unlocks the full potential of health for all. We’re committed to promoting health equity by providing comprehensive, integrated access to pharmacy services, clinical care delivery and digital health through our individualized and culturally competent LGBTQ , HIV, PrEP, and sexual wellness care. Avita is a proud member of the U.S. Business Action to End HIV and has been recognized multiple times by the Human Rights Campaign Foundation as a Best Place to Work for LGBTQ Equality.
Avita is an Equal Opportunity Employer dedicated to building a diverse, inclusive, and authentic workplace. We welcome everyone by recruiting, hiring, and promoting individuals without regard to their sex, race, color, age, national origin, religion, disability, genetic information, marital status, sexual orientation, gender identity, veteran status, or any other status protected by applicable law. Avita also provides reasonable accommodation for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and any other state or local laws.
Avita Care Solutions offers a comprehensive benefits package:
Healthcare benefits (medical, dental, vision) for eligible team members and their families, along with additional company paid and voluntary benefit offerings. Six Company Paid Holidays and Three Personal Floating holidays, Paid Time Off (PTO), Paid Leaves - Two Weeks Paid Parental Leave, Bereavement, Sick Leave, Time to Vote, Jury Duty, Award Recognition Program, Professional Learning & Development opportunities. Company Paid benefits – Basic Life and AD&D, Maven and Health Care Advocate Work/Life Balance Program, Health/Dependent Flexible Spending. Voluntary benefits – Long and Short-term Disability, Pet Insurance, Legal, Accident, Hospital Indemnity, Critical Illness, Whole and Supplementary Life Insurance, Identity Theft Protection, 401(K) Retirement Savings Plan with company match.
All benefits are subject to the applicable plan terms.
