Experience:
5+ years of experience
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Employment Type:
Full time
Posted:
2/20/2019
Job Category:
Legal
Regulatory Compliance Manager
(This job is no longer available)
Turning Point Brands | Louisville, KY
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Job Description

Summary:

The Regulatory Compliance Manager is actively engaged in the execution of plans to ensure compliance with FDA regulations and other regulations concerning the Company's business. The position serves as a vital resource for coordinating sensitive technical information related to regulatory filings as well as a gatekeeper for the Company's contracting processes related to compliance. The Regulatory Compliance Manager is expected to become an active hands-on participant in business decision-making and development, particularly with respect to improvements to legal and compliance processes.

The position will have specific expertise in FDA regulation and select international regulations along with a working knowledge of technical product specifications associated with regulatory filings. This position will also have a working knowledge of basic contract construction as it pertains to compliance initiatives.

Occasional travel will be required. This position reports to the Assistant General Counsel (AGC). The normal shift is 40 hours per week in the office, with periodic extended hours, as needed. This position may be assigned special projects, as determined by the Assistant General Counsel.

Essential Functions:

* Adheres to and applies established compliance programs, recommends changes as necessary or appropriate, and ensures cross-departmental compliance.
* Key responsibility for coordinating data and reports related to international product filing requirements (such as E.U. and Health Canada).
* Understand basic regulatory requirements and apply those requirements to product packaging, advertising, marketing, and social media.
* Prepares routine contracts such as confidentiality / non-disclosure agreements for execution upon request.
* Responsible for maintaining standard contract library, clauses and playbook as developed by counsel, which will be used for third-party compliance initiatives.
* Stays current on tobacco and any tobacco-related legislation and regulations.
* Provides regulatory support for international expansion efforts.
* Performs other duties as assigned by Assistant General Counsel.

Requirements:

* Undergraduate degree in business or paraprofessional legal field preferred.
* At least 5 years working in regulatory/compliance environment is highly preferred.
* Experience working with federal and state agencies in a regulated industry such as tobacco, medical or pharmaceutical industries is preferred; equivalent combination of experience may be considered.
* Must pay attention to detail and work independently using sound judgment, legal research and organizational skills.
* Successful project management experience preferred.
* Must have excellent interpersonal, verbal, written and presentation skills.
* Must be able to work with individuals at all levels of the organization.
* Must have proficiency with computer skills (such as Microsoft Office suite); experience developing and maintaining user databases for technical information and standardized forms is highly preferred.
* Must demonstrate adherence to ethical standards at all times.
* Business acumen, innovation, strategic thinking, professionalism, visionary leadership and problem-solving skills are critical, as it relates to execution, to be the successful candidate.
* Responsible for being knowledgeable of and acting in strict accordance with the requirements of all relevant laws, regulations, and Company policies, including, among other areas, Food and Drug Administration regulations.
* General awareness knowledge of the ISO9001 Quality Management System requirements, company Quality Policy and your contributions to the effectiveness of the QMS.