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  • Franklin Township, NJ 08873

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Licensing Coordinator (Regulatory Compliance Associate)

Catalent Pharma Solutions • Franklin Township, NJ

Posted 22 days ago

Job Snapshot

Full-Time
Travel - None
Pharmaceutical
QA - Quality Control
3

Applicants

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Job Description



Job Description

Licensing Coordinator (Regulatory Compliance Associate)


Position Summary  


A licensing coordinator is responsible for monitoring and documenting various licenses and license renewals. This position is responsible for overseeing Federal (e.g. FDA and DEA) and State Licensing Compliance for Rx and OTC, device, and biologic products under development

and commercial product maintenance.  Position has responsibility to serve as cross-functional lead to ensure partner departments understand their respective roles & responsibilities related to licensing compliance.


The Role

  • Work with in-house Legal and Regulatory Compliance teams to
    • identify required operational licenses for the company
    • interprets federal/state/international regulations as they apply to our products, processes and/or procedures
    • advise on the impact of regulations, devises strategies for compliance, and liaison with regulatory bodies
  • Monitor regulatory environment related to Federal (e.g. FDA and DEA) and State Licensing directly, with assistance from consultants
  • May 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 DEA) and State Licensing compliance, including monitoring all licenses and license renewals and documenting all licenses and license renewals
  • Investigates and resolves 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
  • Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes
  • Provides subject matter expert (SME) consultative support for all regulatory audits, internal and external inspections, and other audits

The Candidate

  • Bachelor’s degree (or foreign equivalent) in life sciences or Regulatory Affairs plus 1 years of experience; or Associate Bachelor’s degree (or foreign equivalent) in life sciences or Regulatory Affairs plus 3 years of experience
  • Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP and DEA
  • Experience preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses, USDA licenses, and DEA licenses 
  • 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

Position Benefits

  • Defined career path and annual performance review and feedback process
  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays

About Catalent


Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to explore career opportunities, or contact us at   

+1 877 503 9493.


Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to [Click Here to Email Your Resumé]. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.



    Job ID: 0025877
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