Sr Regulatory Affairs Specialist
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POST DATE 8/24/2016
END DATE 10/29/2016
JOB DESCRIPTIONSR REGULATORY AFFAIRS SPECIALIST
This position is responsible for ensuring that the company and its subsidiaries maintain DEA compliance. Provide guidance and expertise to Regulatory Affairs in consulting Federal, State, and local government agencies (i.e. DEA, FDA and State Pharmacy and medical boards)..
Research and analyze applicable laws and regulations, develop and implementthe necessary policies and procedures to ensure the Company's ongoingcompliance with Federal,State and local requirements.
* Conducts "Know your Customer" due diligence on customers intending to purchase controlled substances.
* Performs on-site due diligence audits on customers.
* Researches and analyzes laws and regulations to ensure that company's ongoing compliance.
* Develops appropriate compliance awareness training programs and conducts training for sales, field service distribution centers and corporate staff, consistent with regulatory compliance manuals.
* Provides guidance in developing regulatory policies and procedures, maintenance and updates, and appropriate control of documents.
* Provides advice and guidance to the company and its subsidiaries on necessary actions to maintain regulatory compliance.
* Conducts regulatory audits of distribution centers and subsidiaries.
In addition to the essential duties and responsibilities listed above, all positions are responsible for:
*Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including Worldwide Business Standards.
*Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.
*A minimum of three years of experience or the equivalent required in dealing with DEA regulations.
*Working knowledge of auditing requirements and techniques.
Ability to analyze problems and develop solutions, excellent communication and interpersonal skills, detail oriented and ability to work independently.
*Computer skills, including MS Word, MS Excel, flow charts, and obtaining information from mainframe databases, such as AS400.
*Prior Pharmacy, Medical or DEA experience preferred.
*Bachelor's degree or equivalent.
SPECIFIC KNOWLEDGE & SKILLS:
* Thorough understanding of regulations applicable to HS operations.
* Specialized knowledge on a specific Regulatory area.
* Strong understanding of manufacturing, distribution and auditing processes.
* General knowledge of ISO 9000.
TRAVEL/ PHYSICAL DEMANDS:
* Travel typically 10% to 50%.
* Office environment. No special physical demands required.
Henry Schein, Inc. is an Equal Employment Opportunity Employerand does not discriminate against applicants or employees on the basis of race, color, religion,creed, national origin,ancestry, disability that can be reasonably accommodated without undue hardship,sex, sexual orientation, gender identity, age, citizenship, maritalor veteran status,or any other legally protected status