Associate Legal Counsel

Company: Avion Pharmaceuticals
Location: Alpharetta
Posted on: June 23, 2022

Job Description:

JOB TITLE: Associate Counsel STATUS: ExemptDIVISION: Alora Pharmaceuticals, LLC REPORTS TO: VP, General CounselLOCATION: Alpharetta, GA
JOB SUMMARY:
The Associate Counsel will provide legal advice, counsel, and services to ensure that the company is operating in compliance with applicable regulations, investigate and resolve matters, and respond to questions from regulatory authorities. This position will also include advising on product promotion and advertising materials and labeling, as well as the drafting, review, and negotiation of commercial contracts.ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinates with various departments, including Quality Assurance, Sales and Marketing, and Business Development on defining and investigating optimal solutions;
• Advises on and actively participates in the development of company procedures, practices, and systems that ensure compliance with regulatory standards, with particular emphasis on the FDA's quality regulations, PDMA, privacy regulations, and pharmaceutical reporting standards;
• Provides counsel and advice to the company on regulatory and legal-related matters, with particular emphasis on FDA and regulatory issues;
• Participates in the development, revision, review and approval of primary and secondary packaging and drug product labeling;
• Manages the company's portfolio of intellectual property, including trademarks and patents, and corresponds with outside counsel relating to such matters;
• Assists in managing and responding to regulatory agency submissions, investigations, and administrative actions, with particular emphasis on FDA, DEA, HHS, State Boards of Pharmacy, and other issues;
• Provides regulatory reviews and legal analyses of existing products and new product launches;
• Monitors and tracks proposed healthcare-related regulations that will impact the company's business;
• Drafts, negotiates, and facilitates commercial agreements and transactions with outside partners, vendors, customers, and other entities;
• Develops & presents plans to senior-level leadership regarding relevant modifications to existing or proposed regulations that allow for Acella to effectively offer its desired product portfolio.REQUIREMENTS / QUALIFICATIONS:
  • Law degree from an accredited law school, preferably with a focus in Health Policy, Regulatory Affairs, or Intellectual Property;
  • 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.
    BENEFITS:
    • Base salary
    • Full benefits package including medical, dental, vision and disability coverage
    • 401(k) with company match
    • Maternity, paternity and adoption leave
    • Two weeks paid vacation, 9 paid holidays plus floating holidays and sick leaveAvion Pharmaceuticals realizes that our success as an organization is dependent upon our people. If you are motivated by competitive incentive compensation and career advancement measured by your proven successes, we look forward to meeting you.
      Equal Opportunity EmployerAlora Pharmaceuticals, LLC is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.
      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.

Keywords: Avion Pharmaceuticals, Alpharetta , Associate Legal Counsel, Legal , Alpharetta, Georgia