Regulatory Affairs Specialist

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

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.

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.