Licensing Compliance Specialist

Licensing Compliance Specialist

Position Overview

Primary functions of the Licensing Compliance Specialist are (1) overseeing Federal (e.g. FDA) and State Licensing Compliance for Rx products at the Greenville site (including development and commercial product maintenance), (2) coordinating and facilitating Federal and State Open Payment/Transparency reporting monitoring and documenting various licenses and license renewals for the Greenville facility, (2) day-to-day operations related to client requests for regulatory information, (3) maintaining site regulatory documents (e.g. Site Master File). The position serves as cross-functional lead to ensure partner departments understand their respective roles & responsibilities related to licensing compliance.

Work hours: Monday–Friday business hours, site based

The Role

• Create and support the Greenville licensing program and assure it aligns with all Federal, State and Corporate requirements
• Work with in-house Legal and Regulatory Compliance teams to:
  • Identify required operational licenses for the company
  • Interpret federal/state/international regulations as they apply to our products, processes and/or procedures
  • Advise on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies
  • Solicit and report payments made by the organization which must be reported per US Federal and State requirements
• Interact with outside parties and consultants, including negotiating regulatory issues with Federal and state agencies as directed by leadership
• Manage daily activities related to the Federal (e.g. FDA) and State Licensing compliance, including monitoring all licenses and license renewals and documenting all licenses and license renewals
• Investigate and resolve compliance problems and questions
• Work with sites to respond to regulatory agency inquiries
• Assist in resolving licensing issues as needed
• Monitor, process and document licenses and license renewals
• Provide subject matter expert (SME) consultative support for all regulatory audits, internal and external inspections, and other audits
• Other duties as assigned

The Candidate

• Bachelor’s degree required in science or technical field
• At least 5 years relevant Quality or Regulatory experience in pharmaceutical industry
• Experience preparing submissions for US State licenses and Open Payment submissions
• Experience applying 21 CFR 205, 207 and 1301 and related regulations
• Experience and capability to pull data and provide supporting documentation in a timely manner when faced with limited time and resources
• Experience developing automated queries and report using Excel or other similar programs
• Experience interacting with virtual teams
• Strong knowledge of all current state, federal and local standards and regulations, e.g., US State Licensing requirements, Open Payments requirements, FDA cGMP, and some knowledge of US DEA licensing and reporting requirements
• Technical and quality background related to pharmaceuticals

Why you should join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Employee Stock Purchase Program
• Competitive salary with bonus potential
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.