Regulatory Affairs Specialist - Empower Pharmacy

Position Summary:

The Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements related to the development, manufacturing, and distribution of our products. This role will work closely with cross-functional teams to implement regulatory strategies, monitor and interpret changes in regulations, and ensure that Empower's operations are aligned with the latest industry standards and best practices.

Duties and Responsibilities:

• Interprets and ensures compliance with federal, state, and local regulations governing compounding pharmacies including all relevant FDA (Food and Drug Administration) 503A and 503B Guidance's, FDA Essential Copy Guidance, etc.
• Assists in research, including but not limited to clinical trials, case studies, meta-analyses, off and on label studies to substantiate claims.  
• Collaborates with the promotional review team on internal and external educational materials. 
• Works with the various cross-functional departments such as Compliance to provide research for onboarding new clinics, maintaining clinic relations and assisting in clinical discussions.   
• Assists in the investigation, research and development of new product requests and launches. 
• Assists in preparing and presenting training for cross-departmental education on new products.  
• Collaborates with cross-functional teams to implement and maintain quality systems and processes that meet regulatory standards.
• Conducts regular audits and assessments to identify and address any compliance gaps.
• Analyzes marketing and promotional materials to ensure accuracy and compliance with applicable regulations and company policies.
• Prepares, reviews, and submits regulatory documentation, including drug regulatory assessments, drug utilization reports, FDA Bulks list nominations, etc.
• Maintains a comprehensive and up-to-date repository of regulatory documents.
• Responsible for updating knowledge base systems.  
• Assists in the development and review of Standard Operating Procedures (SOPs) to ensure regulatory compliance.
• Stays informed about changes in regulations and guidelines relevant to compounding pharmacies.
• Provides proactive regulatory guidance to internal stakeholders on the impact of regulatory changes on operations and product development.
• Stays informed on evolving advocacy landscape by providing updates to stakeholders and proactively engaging in ongoing efforts.
• Advocates for policies that align with the company's objectives.
• Interfaces with regulatory agencies, as needed, to facilitate clear communication and resolve regulatory issues.
• Supports business relationships that positively impact our ability to continue delivering our products to the current markets in which we operate.  
• Builds and maintains relationships with regulatory authorities including trade associations, ensuring positive interactions and a favorable regulatory environment.
• Works with the Medical Affairs team on all ongoing projects.   
• Performs other duties as assigned.

 

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions. 

 

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. 

Knowledge and Skills:

• In-depth knowledge of FDA regulations and guidelines for compounding pharmacies.
• Strong understanding of cGMP and other quality standards applicable to pharmaceutical compounding.
• Detail-oriented with strong analytical and problem-solving abilities.
• Understands pharmacology and pathophysiology of therapeutical areas including but not limited to: Dermatology, IV Therapy, Women and Men’s Health, Hormone Replacement, Weight Management and Fertility.  
• Ability to comprehend, articulate and apply clinical trials and research to pharmaceutical new product development.   
• Commitment to continuous professional development, with a keen interest in staying informed about the latest advancements in medicine, pharmacology, and healthcare communication.
• Demonstrated ability to create and execute a strategic content plan that addresses healthcare topics, patient concerns, and industry trends, positioning the organization as a thought leader.
• Proven track record of adhering to deadlines and managing multiple projects simultaneously, demonstrating excellent organizational and time-management skills.
• Familiarity with the principles of patient education and engagement, and a passion for empowering patients through informative and accessible content.

 

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and other accountable to meet commitment.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Experience and Qualifications:

• Bachelor's degree, Life Sciences, healthcare or related field required; PharmD preferred.
• 3 years minimum proven experience working in regulatory affairs within the pharmaceutical or compounding pharmacy industry required.

Benefits:

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
• Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
• Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.

 

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
• Critical Illness: Protect your finances from the expenses of a serious health issue.
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
• Legal Services: Access professional legal assistance to address concerns confidently.
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
• Pet Insurance: Care for your furry family members with our pet insurance coverage.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.