The Commercial Regulatory Affairs Manager independently provides regulatory guidance and expertise to Promotional Review Committee (PRC) and Medical, Regulatory, and Legal team members. This individual identifies regulatory requirements and data needed to ensure claims are supported for drug products. During the developmental stage, the Commercial Regulatory Affairs Manager is responsible for providing promotional regulatory guidance for creation of the package insert and the patient package insert to enhance marketing of Neos drugs within regulatory compliance. This position provides regulatory support in FDA meeting preparation and interacts with the reviewing staff at FDA Office of Prescription Drug Promotion (OPDP).
Key Job Functions and Responsibilities:
• Executes regulatory activities and provides regulatory support on projects in accordance with applicable regulations and guidelines
• Ensures regulatory compliance of promotional materials
• Collaborates with PRC team and executes promotional campaigns with some oversight
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for given claims
• Understands broad concepts within regulatory affairs and implications across organization; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies
• Plans, executes and manages regulatory OPDP submissions
• Mentors and provides guidance to more junior regulatory personnel
• Reviews competitive materials globally as needed and interacts with FDA to urge enforcement activity as necessary
• Maintains a high level of expertise through reading and participation at professional seminars, workshops
• Updates senior management on regulatory developments and changes.
• Makes recommendations on adjusting internal policy, procedures or practices when necessary
• Exercises outstanding judgment in all areas of responsibility
• Ensures policies, legislation and procedures are adhered to; including company
SOPs, 21 CFR Part 11 and Sarbanes-Oxley (SOX) compliance.
• Performs other duties as required
• Leadership: This position demonstrates leadership ability by acting as an important part of the Neos Therapeutics team and mentoring junior regulatory personnel.
• Supervision: Receive guidance with respect to general objectives; in the majority of tasks and projects assigned, determine work sequence, scheduling, and how to achieve objectives of assignments while operating within specific policy guidelines.
• Bachelor's degree required.
• Minimum five years pharmaceutical industry inclusive of greater than 3 years related experience.
• Experience in reviewing, authoring, or managing components of regulatory submissions or promotion and advertising materials or related activities.
• Knowledge of FDA regulations.
• Understanding of scientific principles and regulatory/quality systems relevant to drug development.
• Experience in reviewing, authoring, or managing components of regulatory submissions for promotion and advertising materials.
• Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
• Able to deal with issues of critical importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
• Demonstrates problem-solving ability and generates alternative solutions.
• Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion.
• Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation.
• Works well with others, especially within cross-functional teams and management of direct reports.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Proficient in Microsoft Office Suite
• Well-lit, heated and/or air-conditioned indoor office/production setting with adequate ventilation