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The Regulatory Affairs Attorney will provide legal advice, counsel, and services to ensure that the organization is operating in compliance with applicable regulations, investigate and resolve matters, and respond to questions from regulatory authorities. Position will also include advising on product promotion and advertising materials and labeling.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Coordinates with various departments, including Quality Assurance and sales and promotion, on defining and investigating optimal solutions;
Advise, counsel, and actively participate in the development of procedures, practices, and systems that ensure compliance with regulatory standards, with particular emphasis on the FDA’s quality system, PDMA, and pharmaceutical reporting standards;
Provide counsel and advice to the company on regulatory and legal- related matters, with particular emphasis on FDA and regulatory issues;
Coordinates the development, revision, review and approval of primary and secondary labeling;
Contributes to the continuous improvement of the end to end labeling process;
Assists in managing and responding to regulatory agency investigations and administrative actions, with particular emphasis on FDA, DEA, HHS and other issues;
Provides regulatory reviews and analyses of existing products and new product launches;
Monitors and tracks proposed healthcare-related regulations that will impact the company’s business; and
Develops & presents plans to senior-level leadership that result in modifications to existing or proposed regulations that allow for Acella to offer complete array of product portfolio.
REQUIREMENTS / QUALIFICATIONS:
Law degree from an accredited law school, preferably with a focus in Health Policy or Regulatory Affairs;
Licensed to practice law in the state of Georgia;
Minimum of 5 years’ experience, with experience related to Title 21 of the Code of Federal Regulations and other law applicable to the pharmaceutical industry, and also advertisement and promotional review (related industry experience will be considered);
Strong knowledge of FDA requirements, and applicable submission and reporting processes;
Demonstrated ability to make appropriate, autonomous decisions;
Excellent verbal and written communication, negotiation and collaboration skills;
In-house experience in a pharmaceutical company preferred, although relevant experience in law firm or government will be considered.
All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties as requested by their supervisor. This document does not create an employment contract, implied or otherwise, other than an “at-will” employment relationship.
About Avion Pharmaceuticals, LLC
Avion is a specialty pharmaceutical company that develops and markets a growing portfolio of innovative, branded prescription pharmaceutical and dietary supplement products in women’s health, hematology, dermatology, and related specialties.
Avion focuses on identifying opportunities to acquire and enhance the market potential of innovative, commercially available dietary supplements, therapeutics and late-stage development products to fulfill unmet medical and dietary needs.