Sr. Regulatory Specialist

THE POSITION:

The Senior Regulatory Specialist manages regulatory compliance programs with an emphasis on licensure regulatory intelligence controlled substance due diligence and operational regulatory support within pharmaceutical distribution and 3PL environments.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:

• Manage End-to-End Licensing Compliance

Lead the preparation submission renewal and maintenance of all state and federal licenses including coordination with third-party vendors and internal stakeholders and validation of corporate officers designated representatives and supporting licensure requirements.

• Maintain Licensing Records & Inspection Readiness

Ensure accurate audit-ready documentation of all facility licenses and supporting materials including timely availability for regulatory inspections client requests and internal reviews.

• Lead Regulatory Intelligence & Impact Assessment

Monitor and interpret regulatory updates from BOP DOH FDA DEA and industry organizations (e.g. NABP ASHP APHA) and assess applicability to operations and compliance programs.

• Drive Regulatory Implementation & Governance

Maintain regulatory intelligence reporting processes and support the integration of regulatory changes into SOPs operational controls and business processes.

• Provide Operational Regulatory Support

Support distribution and client operations by addressing regulatory inquiries including customer licensure verification shipment compliance requirements and alignment with applicable regulations.

• Execute Controlled Substance Due Diligence & Monitoring

Conduct risk-based due diligence on customers handling controlled substances including onboarding and periodic reviews evaluating licensure regulatory standing and business activity and investigating and escalating suspicious or abnormal orders through monitoring systems.

• Support Controlled Substance Compliance Program Effectiveness

Collaborate cross-functionally to determine appropriate disposition of controlled substance orders maintain documentation of due diligence decisions and support continuous improvement of suspicious order monitoring and customer due diligence procedures to ensure alignment with DEA and state requirements.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position please contact Human Resources.

EXPECTATIONS OF THE JOB:

• Travel: Occasional travel may be required less than 20%
• Hours: 40 Hours per week

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Qualifications :

MINIMUM KNOWLEDGE SKILLS AND ABILITIES:

The requirements listed below are representative of the experience education knowledge skill and/or abilities required.

• Education: Bachelors degree or 1-3 years experience equivalent.
• Experience and/or Training:
  • Strong problem-solving risk assessment and impact analysis abilities.
  • Flexible and able to multitask and prioritize competing demands/workflow.
  • Excellent oral and written communication skills.

• Licenses/Certificates (e.g. trade certificates drivers licenses professional certifications etc. required)
• Technology/Equipment (if applicable the proficiencies required to perform the job)

PREFERRED QUALIFICATIONS:

• Education: Bachelors degree with a life sciences discipline.
• Experience and/or Training:
  • 1-3 years in a pharmaceutical environment.
  • Strong problem-solving risk assessment and impact analysis abilities.
  • Flexible and able to multitask and prioritize competing demands/workflow.
  • Excellent oral and written communication skills
• Licenses/Certificates: FL or CA Designated Representative
• Technology/Equipment:
  • Strong MS Office skills (Outlook Word Excel PowerPoint)
  • Basic knowledge of Suspicious Order Monitoring systems.

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach grasp stand and/or sit for long periods of time (up to 90% of the shift) walk talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet with frequent interruptions and multiple demands.

Additional Information :

OUR CULTURAL BELIEFS:

Patient Minded I act with the patients best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone anywhere anytime to achieve results.

Communication Matters I speak up to create transparent thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

Our team is aware of recent fraudulent job offers in the market misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites unsolicited e-mails or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S.  Compensation will be determined based on relevant experience other job-related qualifications/skills and geographic location (to account for comparative cost of living). This role is eligible for hire in select U.S. locations based on business and operational considerations. For a full list of locations visit  information about EVERSANAs benefits package can be found at  EVERSANA reserves the right to modify this base salary range and benefits at any time. 

From EVERSANAs inception Diversity Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer and our employees are people with different strengths experiences and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity but also age disability status veteran status sexual orientation religion and many other parts of ones identity. All of our employees points of view are key to our success and inclusion is everyones responsibility.

Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process please contact us at .

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Remote Work :

No

Employment Type :

Full-time