Senior Regulatory Affairs Specialist

Company: Supernus Pharmaceuticals, Inc.
Location: Rockville
Posted on: June 18, 2022

Job Description:

Job Summary: This position will act as the pharmaceutical product labeling coordinator of several labeling projects at a time from creation of spec to completion. Will work within a collaborative cross-functional team that includes external vendors, internal Regulatory colleagues, Supply Chain, Quality and potentially Commercial Products Manufacturing.Essential Duties & Responsibilities:

• Develop an understanding of FDA and USDA labeling regulations and company policies.
• Act as the project manager for all labeling projects, working with third party vendors to ensure completion of projects.
• Review and critique documents for submission to FDA in support of original applications, pre-approval amendments and post approval supplements and annual reports.
• Review documents for accuracy, clarity, and consistency of content and format; other non-grammatical inconsistencies observed such as with artwork or layout when reviewing material vs expected layouts per regulations
• Review packaging proofs to ensure accuracy and regulatory compliance.
• Develop and maintain paperwork for regulatory, and internal substantiation requirements.
• Works internally with regulatory, clinical, drug delivery sciences, quality and other internal functional areas and with external regulatory agencies to ensure timely regulatory and quality compliance, and to support business objectives as required.
• Other Duties as Assigned.Supervisory Responsibilities:
  • N/AKnowledge & Other Qualifications:
    • Bachelor's degree (Preferred in the sciences)
    • 4+ years' related experience with project management skillset.
    • Experience within the Pharmaceutical Industry highly preferred.
    • Familiarity with labeling-related regulations and industry practice experience highly preferred.
    • Demonstrated capabilities in meticulous work practices and attention to detail.
    • Project management experience with the ability to handle multiple projects at once.
    • Ability to work with vendors to ensure quality and build effective relationships. Other Characteristics:
      • Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
      • Ability of having an innovative and dynamic approach to work.
      • A self-starter able to work independently but comfortable working in a team environment.
      • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
      • Capable of performing other duties as assigned by Management.
      • Authorized to legally work in the United States without visa sponsorship.Physical Requirements/Work Environment/Travel Requirements:
        • Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
        • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
        • The worker is not substantially exposed to adverse environmental conditionsSupernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Keywords: Supernus Pharmaceuticals, Inc., Rockville , Senior Regulatory Affairs Specialist, Other , Rockville, Maryland