Regulatory Assistant

Porzio Bromberg & Newman•Morristown, NJ

19h

About The Position

Regulatory Assistants are responsible for collaborating with team members for the regular maintenance of Porzio Compliance Sciences, LLC’s (“PCS”) products and the performance of compliance services. A Regulatory Assistant on the Licensing Team provides support to deliver quality state filings / applications required to obtain and/or maintain distribution licenses necessary to ship and/or sell drug/device and other life sciences-related product. Responsibilities include assistance with product maintenance, quality control and compliance projects. Other responsibilities may include research, development of professional presentations, and involvement in the marketing of PCS products and services. Regulatory Assistants perform their duties under the direct supervision of Regulatory Analysts, Supervisors and Managers of Quality Control Services, Managers and Directors of Compliance Services, the Executive Vice-President, and other PCS personnel in the delivery of life sciences marketing and sales compliance services.

Requirements

Bachelor’s degree required.
Ability to master the factual, regulatory and technological aspects of subject matter area.
Strong verbal, written, analytical, organizational and interpersonal skills.
Ability to prioritize tasks and meet tight deadlines.
Flexibility in daily work schedule to meet company needs during periods of heavy workload.
Flexibility in schedule to travel on company-related business.
A valid driver's license and ability to transport oneself to off-site project locations independent of mass transit.

Responsibilities

Provide general clerical support, including filing, indexing, and copying.
Assist team with quality control of product content, including reviewing and revising customer state filings and deliverables.
Collaborate with team members to assist with the delivery of premium customer service.
Communicate with various state agencies and professional licensing boards.
Draft general correspondence and status updates.
Assist in performing factual and regulatory research.
Assist in locating pertinent pending legislation related to various areas of life sciences marketing and sales compliance.
Assist in monitoring and tracking multiple deadlines and due dates.
Become proficient at time-keeping.
Develop project management skills.
Proficiency on all applicable computer and web-based programs.
Proficiency in using equipment including, but not limited to, telephones, photocopy machines, and computers.
Perform other work-related duties as assigned.