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Compliance and Regulatory Specialist

2 months ago

Houston, Texas, United States Empower Pharmacy Full time
Company Overview

Empower Pharmacy is a pioneering healthcare organization dedicated to delivering high-quality, affordable medications to countless patients nationwide.

As the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country, we cater to the functional medicine sector.

Our distinctiveness lies in our unwavering commitment to three fundamental values: People, Quality, and Service.

Our team of dedicated professionals collaborates to innovate in manufacturing, distribution, and quality assurance, offering a uniquely integrated approach to healthcare.

By leveraging our comprehensive pharmaceutical supply chain, cutting-edge technology, and a steadfast commitment to excellence, we continuously strive to enhance medication accessibility and affordability.

Joining us means becoming part of a mission. We empower our team to innovate, grow, and effect meaningful change in the healthcare landscape. If you are a visionary who thrives in a dynamic, transformative environment, Empower Pharmacy is your ideal workplace.

Here, you will be encouraged to share your insights, broaden your skill set, and engage in projects that truly make a difference.

We prioritize the well-being of our employees, offering a supportive and engaging workplace where your contributions are recognized and celebrated.

Let’s transform healthcare together. Become part of something remarkable.

Position Summary


The Compliance and Regulatory Specialist will oversee adherence to all regulatory standards concerning the development, production, and distribution of our products.

This position will collaborate closely with various teams to execute regulatory strategies, monitor and interpret regulatory changes, and ensure that Empower Pharmacy's operations align with the latest industry standards and best practices.

Duties and Responsibilities


- Interpret and ensure compliance with federal, state, and local regulations governing compounding pharmacies, including all relevant FDA (Food and Drug Administration) 503A and 503B guidelines.

- Assist in research activities, including clinical trials, case studies, and meta-analyses to substantiate claims.

- Collaborate with the promotional review team on internal and external educational materials.

- Work with various cross-functional departments such as Compliance to provide research for onboarding new clinics, maintaining clinic relations, and assisting in clinical discussions.

- Support the investigation, research, and development of new product requests and launches.

- Assist in preparing and delivering training for cross-departmental education on new products.

- Collaborate with cross-functional teams to implement and maintain quality systems and processes that meet regulatory standards.

- Conduct regular audits and assessments to identify and address compliance gaps.

- Analyze marketing and promotional materials to ensure accuracy and compliance with applicable regulations and company policies.

- Prepare, review, and submit regulatory documentation, including drug regulatory assessments and drug utilization reports.

- Maintain a comprehensive and up-to-date repository of regulatory documents.

- Update knowledge base systems as necessary.

- Assist in the development and review of Standard Operating Procedures (SOPs) to ensure regulatory compliance.

- Stay informed about changes in regulations and guidelines relevant to compounding pharmacies.

- Provide proactive regulatory guidance to internal stakeholders regarding the impact of regulatory changes on operations and product development.

- Stay updated on the evolving advocacy landscape by providing updates to stakeholders and engaging in ongoing efforts.

- Advocate for policies that align with the company's objectives.

- Interface with regulatory agencies as needed to facilitate clear communication and resolve regulatory issues.

- Support business relationships that positively impact our ability to deliver products to current markets.

- Build and maintain relationships with regulatory authorities, ensuring positive interactions and a favorable regulatory environment.

- Collaborate with the Medical Affairs team on ongoing projects.

- Perform other duties as assigned.

To succeed in this role, an individual must be able to perform each essential function satisfactorily.

The requirements listed above represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

While performing the responsibilities of the job, the employee is required to communicate effectively.

The employee is often required to remain stationary for a significant portion of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from computers and other office productivity devices.

The employee is regularly required to move about the office and corporate campus.

The employee may occasionally be 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.

- Understanding of pharmacology and pathophysiology in therapeutic areas including but not limited to: Dermatology, IV Therapy, Women's 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:
Knowledge of the most effective and efficient processes to achieve objectives, with a focus on continuous improvement.

Collaborates:
Builds partnerships and works collaboratively with others to meet shared goals.

Resourcefulness:
Effectively secures and deploys resources.

Manages Complexity:
Makes sense of complex, high-quality, and sometimes contradictory information to effectively solve problems.

Ensures Accountability:
Holds self and others accountable to meet commitments.

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 in Life Sciences, healthcare, or a related field required; PharmD preferred.
- Minimum of 3 years proven experience in regulatory affairs within the pharmaceutical or compounding pharmacy industry required.

Employee Benefits, Health, and Wellness

No-Cost Medication:
Receive prescribed compounded medications at no cost, ensuring your health without 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, providing 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 is acknowledged – enjoy rewards and recognition beyond your paycheck.

Additional Voluntary Benefits

Accident Insurance:
Provides 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.